Pixel array medical systems, devices and methods

ABSTRACT

Systems, instruments, and methods for minimally invasive procedures including one or more of fractional resection, fractional lipectomy, fractional skin grafting, and/or fractional scar revision are described. Embodiments include instrumentation comprising a scalpet assembly coupled to a carrier, and the scalpet assembly includes a scalpet array. The scalpet array includes one or more scalpets configured for fractional resection, fractional lipectomy, fractional skin grafting, and/or fractional scar revision. The system includes a vacuum component coupled to the scalpet assembly and configured to evacuate tissue from the a site. The carrier is configured to control application of a rotational force and/or a vacuum force to the scalpet assembly.

RELATED APPLICATIONS

This application claims the benefit of U.S. (US) Patent Application No.62/456,775, filed Feb. 9, 2017.

This application claims the benefit of U.S. Patent Application No.62/504,844, filed May 11, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 14/556,648, filed Dec. 1, 2014, which is a continuation of U.S.patent application Ser. No. 12/972,013, filed Dec. 17, 2010, now U.S.Pat. No. 8,900,181.

This application is a continuation in part of U.S. patent applicationSer. No. 15/812,952, filed Nov. 14, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 14/099,380, filed Dec. 6, 2013.

This application is a continuation in part of U.S. patent applicationSer. No. 15/821,258, filed Nov. 22, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,090, filed Oct. 2, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,183, filed Oct. 2, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 15/821,325, filed Nov. 22, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,274, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,284, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,267, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,290, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,307, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 15/016,954, filed Feb. 5, 2016.

This application is a continuation in part of U.S. patent applicationSer. No. 15/017,007, filed Feb. 5, 2016.

This application is a continuation in part of U.S. patent applicationSer. No. 15/431,230, filed Feb. 13, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 15/431,247, filed Feb. 13, 2017.

TECHNICAL FIELD

The embodiments herein relate to medical systems, instruments ordevices, and methods and, more particularly, to medical instrumentationand methods applied to the surgical management of burns, skin defects,and hair transplantation.

BACKGROUND

The aging process is most visibly depicted by the development ofdependent skin laxity. This life long process may become evident asearly as the third decade of life and will progressively worsen oversubsequent decades. Histological research has shown that dependantstretching or age related laxity of the skin is due in part toprogressive dermal atrophy associated with a reduction of skin tensilestrength. When combined with the downward force of gravity, age relateddermal atrophy will result in the two dimensional expansion of the skinenvelope. The clinical manifestation of this physical-histologicalprocess is redundant skin laxity. The most affected areas are the headand neck, upper arms, thighs, breasts, lower abdomen and knee regions.The most visible of all areas are the head and neck. In this region,prominent “turkey gobbler” laxity of neck and “jowls” of the lower faceare due to an unaesthetic dependency of skin in these areas.

Plastic surgery procedures have been developed to resect the redundantlax skin. These procedures must employ long incisions that are typicallyhidden around anatomical boundaries such as the ear and scalp for afacelift and the inframammary fold for a breast uplift (mastopexy).However, some areas of skin laxity resection are a poor tradeoff betweenthe aesthetic enhancement of tighter skin and the visibility of thesurgical incision. For this reason, skin redundancies of the upper arm,suprapatellar knees, thighs and buttocks are not routinely resected dueto the visibility of the surgical scar.

The frequency and negative societal impact of this aesthetic deformityhas prompted the development of the “Face Lift” surgical procedure.Other related plastic surgical procedures in different regions are theAbdominoplasty (Abdomen), the Mastopexy (Breasts), and the Brachioplasty(Upper Arms). Inherent adverse features of these surgical procedures arepost-operative pain, scarring and the risk of surgical complications.Even though the aesthetic enhancement of these procedures is anacceptable tradeoff to the significant surgical incisions required,extensive permanent scarring is always an incumbent part of theseprocedures. For this reason, plastic surgeons design these procedures tohide the extensive scarring around anatomical borders such as thehairline (Facelift), the inframmary fold (Mastopexy), and the inguinalcrease (Abdominoplasty). However, many of these incisions are hiddendistant to the region of skin laxity, thereby limiting theireffectiveness. Other skin laxity regions such as the Suprapatellar(upper-front) knee are not amendable to plastic surgical resections dueto the poor tradeoff with a more visible surgical scar.

More recently, electromagnetic medical devices that create a reversethermal gradient (i.e., Thermage) have attempted with variable successto tighten skin without surgery. At this time, these electromagneticdevices are best deployed in patients with a moderate amount of skinlaxity. Because of the limitations of electromagnetic devices andpotential side effects of surgery, a minimally invasive technology isneeded to circumvent surgically related scarring and the clinicalvariability of electromagnetic heating of the skin. For many patientswho have age related skin laxity (neck and face, arms, axillas, thighs,knees, buttocks, abdomen, bra line, ptosis of the breast), fractionalresection of excess skin could augment a significant segment oftraditional plastic surgery.

Even more significant than aesthetic modification of the skin envelopeis the surgical management of burns and other trauma related skindefects. Significant burns are classified by the total body surfaceburned and by the depth of thermal destruction. First-degree andsecond-degree burns are generally managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin. The surgical management of these serious injuries involves thedebridement of the burn eschar and the application of split thicknessgrafts.

Any full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using current commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts, that is,from the same patient. Typically, the donor site on the burn patient ischosen in a non-burned area and a partial thickness sheet of skin isharvested from that area. Incumbent upon this procedure is the creationof a partial thickness skin defect at the donor site. This donor sitedefect is itself similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity is createdthat is permanently thinner and more de-pigmented than the surroundingskin. For patients who have burns over a significant surface area, theextensive harvesting of skin grafts may also be limited by theavailability of non-burned areas.

For these reasons, there is a need in the rapidly expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. There is also a need for systems, instruments or devices,and procedures that enable the repeated harvesting of skin grafts fromthe same donor site while eliminating donor site deformity.

INCORPORATION BY REFERENCE

Each patent, patent application, and/or publication mentioned in thisspecification is herein incorporated by reference in its entirety to thesame extent as if each individual patent, patent application, and/orpublication was specifically and individually indicated to beincorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the PAD Kit placed at a target site, under an embodiment.

FIG. 2 is a cross-section of a scalpet punch or device including ascalpet array, under an embodiment.

FIG. 3 is a partial cross-section of a scalpet punch or device includinga scalpet array, under an embodiment.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment.

FIG. 6 shows the removal of skin pixels, under an embodiment.

FIG. 7 is a side view of blade transection and removal of incised skinpixels with the PAD Kit, under an embodiment.

FIG. 8 is an isometric view of blade/pixel interaction during aprocedure using the PAD Kit, under an embodiment.

FIG. 9 is another view during a procedure using the PAD Kit (bladeremoved for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment.

FIG. 10A is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an embodiment.

FIG. 10B is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an alternative embodiment.

FIG. 10C is a top view of the scalpet plate, under an embodiment.

FIG. 10D is a close view of a portion of the scalpet plate, under anembodiment.

FIG. 11A shows an example of rolling pixel drum, under an embodiment.

FIG. 11B shows an example of a rolling pixel drum assembled on a handle,under an embodiment.

FIG. 11C depicts a drum dermatome for use with the scalpet plate, underan embodiment.

FIG. 12A shows the drum dermatome positioned over the scalpet plate,under an embodiment.

FIG. 12B is an alternative view of the drum dermatome positioned overthe scalpet plate, under an embodiment.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment.

FIG. 13B is a side view of a portion of the drum dermatome showing ablade position relative to the scalpet plate, under an embodiment.

FIG. 13C is a side view of the portion of the drum dermatome showing adifferent blade position relative to the scalpet plate, under anembodiment.

FIG. 13D is a side view of the drum dermatome with another bladeposition relative to the scalpet plate, under an embodiment.

FIG. 13E is a side view of the drum dermatome with the transection bladeclip showing transection of skin pixels by the blade clip, under anembodiment.

FIG. 13F is a bottom view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13H is a back view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 14A shows an assembled view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14B is an exploded view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14C shows a portion of the dermatome with the Pixel Onlay Sleeve(POS), under an embodiment.

FIG. 15A shows the Slip-On PAD being slid onto a Padgett Drum Dermatome,under an embodiment.

FIG. 15B shows an assembled view of the Slip-On PAD installed over thePadgett Drum Dermatome, under an embodiment.

FIG. 16A shows the Slip-On PAD installed over a Padgett Drum Dermatomeand used with a perforated template or guide plate, under an embodiment.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment.

FIG. 17B shows an alternative view of a portion of the Pixel DrumDermatome being applied to a target site of the skin surface, under anembodiment.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment.

FIG. 19B shows a bottom perspective view of the scalpet device for usewith the PAD assembly, under an embodiment.

FIG. 20 shows a side view of the punch impact device including a vacuumcomponent, under an embodiment.

FIG. 21A shows a top view of an oscillating flat scalpet array and bladedevice, under an embodiment.

FIG. 21B shows a bottom view of an oscillating flat scalpet array andblade device, under an embodiment.

FIG. 21C is a close-up view of the flat array when the array ofscalpets, blades, adherent membrane and the adhesive backer areassembled together, under an embodiment.

FIG. 21D is a close-up view of the flat array of scalpets with a feedercomponent, under an embodiment.

FIG. 22 shows a cadaver dermal matrix cylindrically transected similarin size to the harvested skin pixel grafts, under an embodiment.

FIG. 23 is a drum array drug delivery device, under an embodiment.

FIG. 24A is a side view of a needle array drug delivery device, under anembodiment.

FIG. 24B is an upper isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 24C is a lower isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 25 shows the composition of human skin.

FIG. 26 shows the physiological cycles of hair growth.

FIG. 27 shows harvesting of donor follicles, under an embodiment.

FIG. 28 shows preparation of the recipient site, under an embodiment.

FIG. 29 shows placement of the harvested hair plugs at the recipientsite, under an embodiment.

FIG. 30 shows placement of the perforated plate on the occipital scalpdonor site, under an embodiment.

FIG. 31 shows scalpet penetration depth through skin when the scalpet isconfigured to penetrate to the subcutaneous fat layer to capture thehair follicle, under an embodiment.

FIG. 32 shows hair plug harvesting using the perforated plate at theoccipital donor site, under an embodiment.

FIG. 33 shows creation of the visible hairline, under an embodiment.

FIG. 34 shows preparation of the donor site using the patternedperforated plate and spring-loaded pixilation device to create identicalskin defects at the recipient site, under an embodiment.

FIG. 35 shows transplantation of harvested plugs by inserting harvestedplugs into a corresponding skin defect created at the recipient site,under an embodiment.

FIG. 36 shows a clinical end point using the pixel dermatomeinstrumentation and procedure, under an embodiment.

FIG. 37 is an image of the skin tattooed at the corners and midpoints ofthe area to be resected, under an embodiment.

FIG. 38 is an image of the post-operative skin resection field, under anembodiment.

FIG. 39 is an image at 11 days following the procedure showingresections healed per primam, with measured margins, under anembodiment.

FIG. 40 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured margins, under an embodiment.

FIG. 41 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured lateral dimensions, under anembodiment.

FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primam,with measured lateral dimensions, under an embodiment.

FIG. 43 is a scalpet showing the applied rotational and/or impactforces, under an embodiment.

FIG. 44 shows a geared scalpet and an array including geared scalpets,under an embodiment.

FIG. 45 is a bottom perspective view of a resection device including thescalpet assembly with geared scalpet array, under an embodiment.

FIG. 46 is a bottom perspective view of the scalpet assembly with gearedscalpet array (housing not shown), under an embodiment.

FIG. 47 is a detailed view of the geared scalpet array, under anembodiment.

FIG. 48 shows an array including scalpets in a frictional driveconfiguration, under an embodiment.

FIG. 49 shows a helical scalpet (external) and an array includinghelical scalpets (external), under an embodiment.

FIG. 50 shows side perspective views of a scalpet assembly including ahelical scalpet array (left), and the resection device including thescalpet assembly with helical scalpet array (right) (housing shown),under an embodiment.

FIG. 51 is a side view of a resection device including the scalpetassembly with helical scalpet array assembly (housing depicted astransparent for clarity of details), under an embodiment.

FIG. 52 is a bottom perspective view of a resection device including thescalpet assembly with helical scalpet array assembly (housing depictedas transparent for clarity of details), under an embodiment.

FIG. 53 is a top perspective view of a resection device including thescalpet assembly with helical scalpet array assembly (housing depictedas transparent for clarity of details), under an embodiment.

FIG. 54 is a push plate of the helical scalpet array, under anembodiment.

FIG. 55 shows the helical scalpet array with the push plate, under anembodiment.

FIG. 56 shows an inner helical scalpet and an array including innerhelical scalpets, under an embodiment.

FIG. 57 shows the helical scalpet array with the drive plate, under anembodiment.

FIG. 58 shows a slotted scalpet and an array including slotted scalpets,under an embodiment.

FIG. 59 shows a portion of a slotted scalpet array (e.g., four (4)scalpets) with the drive rod, under an embodiment.

FIG. 60 shows an example slotted scalpet array (e.g., 25 scalpets) withthe drive rod, under an embodiment.

FIG. 61 shows an oscillating pin drive assembly with a scalpet, under anembodiment.

FIG. 62 shows variable scalpet exposure control with the scalpet guideplates, under an embodiment.

FIG. 63 shows a scalpet assembly including a scalpet array (e.g.,helical) configured to be manually driven by an operator, under anembodiment.

FIG. 64 shows forces exerted on a scalpet via application to the ski.

FIG. 65 depicts steady axial force compression using a scalpet, under anembodiment.

FIG. 66 depicts steady single axial force compression plus kineticimpact force using a scalpet, under an embodiment.

FIG. 67 depicts moving of the scalpet at a velocity to impact and piercethe skin, under an embodiment.

FIG. 68 depicts a multi-needle tip, under an embodiment.

FIG. 69 shows a square scalpet without teeth (left), and a squarescalpet with multiple teeth (right), under an embodiment.

FIG. 70 shows multiple side, front (or back), and side perspective viewsof a round scalpet with an oblique tip, under an embodiment.

FIG. 71 shows a round scalpet with a serrated edge, under an embodiment.

FIG. 72 shows a side view of the resection device including the scalpetassembly with scalpet array and extrusion pins (housing depicted astransparent for clarity of details), under an embodiment.

FIG. 73 shows a top perspective cutaway view of the resection deviceincluding the scalpet assembly with scalpet array and extrusion pins(housing depicted as transparent for clarity of details), under anembodiment.

FIG. 74 shows side and top perspective views of the scalpet assemblyincluding the scalpet array and extrusion pins, under an embodiment.

FIG. 75 is a side view of a resection device including the scalpetassembly with scalpet array assembly coupled to a vibration source,under an embodiment.

FIG. 76 shows a scalpet array driven by an electromechanical source orscalpet array generator, under an embodiment.

FIG. 77 is a diagram of the resection device including a vacuum system,under an embodiment.

FIG. 78 shows a vacuum manifold applied to a target skin surface toevacuate/harvest excised skin/hair plugs, under an embodiment.

FIG. 79 shows a vacuum manifold with an integrated wire mesh applied toa target skin surface to evacuate/harvest excised skin/hair plugs, underan embodiment.

FIG. 80 shows a vacuum manifold with an integrated wire mesh configuredto vacuum subdermal fat, under an embodiment.

FIG. 81 depicts a collapsible docking station and an inserted skinpixel, under an embodiment. The docking station is formed fromelastomeric material but is not so limited.

FIG. 82 is a top view of a docking station (e.g., elastomeric) instretched (left) and un-stretched (right) configuration, under anembodiment, under an embodiment.

FIG. 83 depicts removal of lax excess skin without apparent scarring,under an embodiment.

FIG. 84 depicts tightening of skin without apparent scaring, under anembodiment.

FIG. 85 depicts three-dimensional contouring of the skin envelop, underan embodiment.

FIG. 86 depicts variable fractional resection densities in a treatmentarea, under an embodiment.

FIG. 87 depicts fractional resection of fat, under an embodiment.

FIG. 88 depicts cobblestoning of the skin surface.

FIG. 89 depicts topographic mapping for a deeper level of fractional fatresection, under an embodiment.

FIG. 90 depicts multiple treatment outlines, under an embodiment.

FIG. 91 depicts a curvilinear treatment pattern, under an embodiment.

FIG. 92 depicts a digital image of a patient with rendered digital wiremesh program, under an embodiment.

FIG. 93 depicts directed closure of a fractionally resected field, underan embodiment.

FIG. 94 depicts directed fractional resection of skin, under anembodiment.

FIG. 95 depicts shortening of incisions through continuity fractionalprocedures, under an embodiment.

FIG. 96 is an example depiction of “dog ear” skin redundancies in breastreduction and abdominoplasty.

FIG. 97 is a sPAD including a skived single scalpet with depth control,under an embodiment.

FIG. 98 is a sPAD including a standard single scalpet, under anembodiment.

FIG. 99 is a sPAD including a pencil-style gear reducing handpiece,under an embodiment.

FIG. 100 is a sPAD including a 3×3 centerless array, under anembodiment.

FIG. 101 is a sPAD including a cordless surgical drill for large arrays,under an embodiment.

FIG. 102 is a sPAD comprising a drill mounted 5×5 centerless array,under an embodiment.

FIG. 103 is a sPAD including a vacuum assisted pneumatic resection sPAD,under an embodiment.

FIG. 104 is a VAPR sPAD coupled to a drill via a DAC, under anembodiment.

FIG. 105 depicts the VAPR sPAD in a ready state (left), and an extendedtreatment state (right), under an embodiment.

FIG. 106 depicts the SAVR sPAD in a ready state (left), and a retractedstate (right), under an embodiment.

FIG. 107A is a cross-sectional side view of a carrier including a vacuummanifold, under an embodiment.

FIG. 107B is an isometric cross-sectional side view of the carrierincluding the vacuum manifold, under an embodiment.

FIG. 107C is a side view of the carrier including the vacuum manifold,under an embodiment.

FIG. 108 is a solid side view of the carrier with the vacuum manifoldconfigured for manual control via an aperture, under an embodiment.

FIG. 109A is an isometric view of a handpiece configured to include orincorporate vacuum, under an embodiment.

FIG. 109B is an isometric cutaway view of the handpiece configured toinclude or incorporate vacuum, under an embodiment.

FIG. 110A is a cross-sectional side view of a vacuum manifold configuredto be coupled or connected to an in-line vacuum component, under anembodiment.

FIG. 110B is an isometric cross-sectional view of a vacuum manifoldconfigured to be coupled or attached to an in-line vacuum component,under an embodiment.

FIG. 110C is a solid side view of a vacuum manifold configured to becoupled or attached to an in-line vacuum component, under an embodiment.

FIG. 111A is a cross-sectional side view of a scalpet array used with avacuum aspirator, under an alternative embodiment.

FIG. 111B is an isometric cross-sectional view of a scalpet array usedwith a vacuum aspirator, under an embodiment.

FIG. 111C is a side view of a scalpet array used with a vacuumaspirator, under an embodiment.

FIG. 112 is a cross-sectional side view of a single-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 113 is an isometric cross-sectional view of a single-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 114A is a cross-sectional side view of a multi-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 114B is an isometric cross-sectional view of a multi-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 115 is an example scalpet including apertures or slots, under anembodiment.

FIG. 116 is an example blunt micro-tip scalpet or cannula includingapertures or slots, under an embodiment.

FIG. 117 is an example negative stencil marking system, under anembodiment.

FIG. 118 is an example positive stencil marking system, under anembodiment.

FIG. 119A shows a side view of the ASPPMP in use as a depth guide withthe single-scalpet device, under an embodiment.

FIG. 119B shows a top isometric view of the ASPPMP in use as a depthguide with the single-scalpet device, under an embodiment.

FIG. 120 shows fractional resection of skin and fractionalsubdermal/subcutaneous lipectomy, under an embodiment.

FIG. 121 shows a side view of the submentum as a target area forfractional resection of skin and fractional subdermal/subcutaneouslipectomy, under an embodiment.

FIG. 122 shows an inferior view (looking upward) of the fractionalresection field submentum as a target area for fractional resection ofskin and fractional subdermal/subcutaneous lipectomy, under anembodiment.

FIG. 123 shows a horizontally aligned treatment area in the submentumand lateral neck for severe skin laxity, under an embodiment.

FIG. 124 shows broader fractional lipectomy in the submentum for severelipodystrophy, under an embodiment.

FIG. 125 shows example face vector and neck vector directed closures,under an embodiment.

FIG. 126 shows Langer's lines of closure.

FIG. 127 shows marked target areas for fractional resection of neck andsubmental lipectomy, under an embodiment.

FIG. 128 shows an example stencil, under an embodiment.

FIG. 129 shows example directed closure vectors of the submentum andanterior neck, under an embodiment.

FIG. 130 depicts Z-plasty and W-plasty scar revision.

FIG. 131 shows an example of the fractional de-delineation technique ofscar resection, under an embodiment.

FIG. 132 shows an example of the fractional scar resection for broadhypotrophic scars, under an embodiment.

FIG. 133 shows an example comprising shortening of the inframmaryincision as applied to breast reduction and/or breast repositioning,under an embodiment.

FIG. 134 shows an example flap closure.

FIG. 135 shows an example comprising fractional skin graft harvesting tobe applied to a donor site, under an embodiment.

FIG. 136 shows an example comprising neovascularization of a fractionalskin graft at a recipient site, under an embodiment.

FIG. 137 shows an example docking station comprising a docking tray andadjustable slides, under an embodiment.

DETAILED DESCRIPTION

Systems, instruments, and methods for minimally invasive proceduresincluding one or more of fractional resection, fractional lipectomy,fractional skin grafting, and/or fractional scar revision are described.Embodiments include instrumentation comprising a scalpet assemblycoupled to a carrier, and the scalpet assembly includes a scalpet array.The scalpet array includes one or more scalpets configured forfractional resection, fractional lipectomy, fractional skin grafting,and/or fractional scar revision. The system includes a vacuum componentcoupled to the scalpet assembly and configured to evacuate tissue fromthe a site. The carrier is configured to control application of arotational force and/or a vacuum force to the scalpet assembly.

The scalpet device described herein satisfies the expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. Additionally, the embodiments enable the repeated harvestingof skin grafts from the same donor site while eliminating donor sitedeformity. The embodiments described herein are configured to resectredundant lax skin without visible scarring so that all areas ofredundant skin laxity can be resected by the pixel array dermatome andprocedures may be performed in areas that were previously off limits dueto the visibility of the surgical incision. The technical effectsrealized through the embodiments described herein include smooth,tightened skin without visible scarring or long scars along anatomicalborders.

Embodiments described in detail herein, which include pixel skingrafting instrumentation and methods, are configured to provide thecapability to repeatedly harvest split thickness skin grafts withoutvisible scarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) is used to harvest the skin graft from the chosen donorsite. During the harvesting procedure, a pixilated skin graft isdeposited onto a flexible, semi-porous, adherent membrane. The harvestedskin graft/membrane composite is then applied directly to the recipientskin defect site. The fractionally resected donor site is closed withthe application of an adherent sheeting or bandage (e.g., Flexzan®sheeting, etc.) that functions for a period of time (e.g., one week,etc.) as a large butterfly bandage. The intradermal skin defectsgenerated by the PAD are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring postoperatively,the adherent membrane is desquamated (shed) with the stratum corneum ofthe graft; the membrane can then be removed without disruption of thegraft from the recipient bed.

Numerous effects realized by the pixel skin grafting procedure deserveexplanation. Because the skin graft is pixelated it provides intersticesfor drainage between skin plug components, which enhances the percentageof “takes,” compared to sheet skin grafts. During the firstpost-operative week, the skin graft “takes” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semiporousmembrane conducts the exudate into the dressing.

The flexible membrane is configured with an elastic recoil property thatpromotes apposition of component skin plugs within the graft/membranecomposite; promoting primary adjacent healing of the skin graft plugsand converting the pixilated appearance of the skin graft into a moreuniform sheet morphology. Furthermore, the membrane aligns themicro-architectural components skin plugs, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring.

There are numerous major clinical applications for the dermatomesdescribed in detail herein, including fractional skin resection for skintightening, fractional hair grafting for alopecia, and fractional skinharvesting for skin grafting. Fractional skin resection of an embodimentcomprises harvesting skin plugs using an adherent membrane, however thefractionally incised skin plugs can be evacuated without harvesting. Theparadigm of incising, evacuating and closing is most descriptive of theclinical application of skin tightening. The embodiments describedherein are configured to facilitate incising and evacuating and, inorder to provide for a larger scalpet array with a greater number ofscalpets, the embodiments include a novel means of incising the skinsurface.

Pixel array medical systems, instruments or devices, and methods aredescribed for skin grafting and skin resection procedures, and hairtransplantation procedures. In the following description, numerousspecific details are introduced to provide a thorough understanding of,and enabling description for, embodiments herein. One skilled in therelevant art, however, will recognize that these embodiments can bepracticed without one or more of the specific details, or with othercomponents, systems, etc. In other instances, well-known structures oroperations are not shown, or are not described in detail, to avoidobscuring aspects of the disclosed embodiments.

The following terms are intended to have the following general meaningas they may be used herein. The terms are not however limited to themeanings stated herein as the meanings of any term can include othermeanings as understood or applied by one skilled in the art.

“First degree burn” as used herein includes a superficial thermal injuryin which there is no disruption of the epidermis from the dermis. Afirst-degree burn is visualized as erythema (redness) of the skin.

“Second degree burn” as used herein includes a relatively deeper burn inwhich there is disruption of the epidermis from the dermis and where avariable thickness of the dermis is also denatured. Most second-degreeburns are associated with blister formation. Deep second-degree burnsmay convert to full thickness third degree burns, usually by oxidationor infection.

“Third degree burn” as used herein includes a burn associated with thefull thickness thermal destruction of the skin including the epidermisand the dermis. A third degree burn may also be associated with thermaldestruction of deeper, underlying tissues (subcutaneous and musclelayers).

“Ablation” as used herein includes the removal of tissue by destructionof the tissue e.g., thermal ablation of a skin lesion by a laser.

“Autograft” as used herein includes a graft taken from the same patient.

“Backed Adherent Membrane” as used herein includes the elastic adherentmembrane that captures the transected skin plugs. The Backed AdherentMembrane of an embodiment is backed on the outer surface to retainalignment of the skin plugs during harvest. After harvesting of the skinplugs, the backing is removed from the adherent membrane with harvestedskin plugs. The membrane of an embodiment is porous to allow fordrainage when placed at the recipient site. The membrane of anembodiment also possesses an elastic recoil property, so that when thebacking is removed, it brings the sides of the skin plugs closer to eachother to promote healing at the recipient site as a sheet graft.

“Burn Scar Contraction” as used herein includes the tightening of scartissue that occurs during the wound healing process. This process ismore likely to occur with an untreated third degree burn.

“Burn Scar Contracture” as used herein includes a band of scar tissuethat either limits the range of motion of a joint or band of scar tissuethat distorts the appearance of the patient i.e., a burn scarcontracture of the face.

“Dermatome” as used herein includes an instrument that “cuts skin” orharvests a sheet split thickness skin graft. Examples of drum dermatomesinclude the Padgett and Reese dermatomes. Electrically powereddermatomes are the Zimmer dermatome and one electric version of thePadgett dermatome.

“Dermis” as used herein includes the deep layer of skin that is the mainstructural support and primarily comprises non-cellular collagen fibers.Fibroblasts are cells in the dermis that produce the collagen proteinfibers.

“Donor Site” as used herein includes the anatomical site from which askin graft is harvested.

“Epidermis” as used herein includes the outer layer of skin comprisingviable epidermal cells and nonviable stratum corneum that acts as abiological barrier.

“Excise” as used herein includes the surgical removal of tissue.

“Excisional Skin Defect” as used herein includes a partial thickness or,more typically, a full thickness defect that results from the surgicalremoval (excision/resection) of skin (lesion).

“FTSG” as used herein includes a Full Thickness Skin Graft in which theentire thickness of the skin is harvested. With the exception of aninstrument as described herein, the donor site is closed as a surgicalincision. For this reason, FTSG is limited in the surface area that canbe harvested.

“Granulation Tissue” as used herein includes highly vascularized tissuethat grows in response to the absence of skin in a full-thickness skindefect. Granulation Tissue is the ideal base for a skin graft recipientsite.

“Healing by primary intention” as used herein includes the wound healingprocess in which normal anatomical structures are realigned with aminimum of scar tissue formation. Morphologically the scar is lesslikely to be visible.

“Healing by secondary intention” as used herein includes a lessorganized wound healing process wherein healing occurs with lessalignment of normal anatomical structures and with an increaseddeposition of scar collagen. Morphologically, the scar is more likely tobe visible.

“Homograft” as used herein includes a graft taken from a different humanand applied as a temporary biological dressing to a recipient site on apatient. Most homografts are harvested as cadaver skin. A temporary“take” of a homograft can be partially achieved with immunosuppressionbut homografts are eventually replaced by autografts if the patientsurvives.

“Incise” as used herein includes the making of a surgical incisionwithout removal of tissue.

“Mesh Split Thickness Skin Graft” as used herein includes a splitthickness skin graft that is expanded in its surface area byrepetitiously incising the harvested skin graft with an instrumentcalled a “mesher”. A meshed split thickness skin graft has a higherpercentage of “take” than a sheet graft because it allows drainagethrough the graft and conforms better to the contour irregularities ofthe recipient site. However, it does result in an unsightly reticulatedappearance of the graft at the recipient site.

“PAD” as used herein includes a Pixel Array Dermatome, the class ofinstruments for fractional skin resection.

“PAD Kit” as used herein includes the disposable single use procedurekit comprising the perforated guide plate, scalpet stamper, the guideplate frame, the backed adherent membrane and the transection blade.

“Perforated Guide Plate” as used herein includes a perforated platecomprising the entire graft harvest area in which the holes of the guideplate are aligned with the scalpets of the handled stamper or theSlip-on PAD. The plate will also function as a guard to preventinadvertent laceration of the adjacent skin. The perforations of theGuide Plate can be different geometries such as, but not limited to,round, oval, square. rectangular, and/or triangular.

“Pixelated Full Thickness Skin Graft” as used herein includes a FullThickness Skin Graft that has been harvested with an instrument asdescribed herein without reduced visibly apparent scarring at the donorsite. The graft will also possess an enhanced appearance at therecipient site similar to a sheet FTSG but will conform better torecipient site and will have a higher percentage of ‘take’ due todrainage interstices between skin plugs. Another significant advantageof the pixelated FTSG in comparison to a sheet FTSG is the ability tograft larger surface areas that would otherwise require a STSG. Thisadvantage is due to the capability to harvest from multiple donor siteswith reduced visible scarring.

“Pixelated Graft Harvest” as used herein includes the skin graftharvesting from a donor site by an instrument as described in detailherein.

“Pixelated Spilt Thickness Skin Graft” as used herein includes a partialthickness skin graft that has been harvested with an SRG instrument. Theskin graft shares the advantages of a meshed skin graft withoutunsightly donor and recipient sites.

“Recipient Site” as used herein includes the skin defect site where askin graft is applied.

“Resect” as used herein includes excising.

“Scalpel” as used herein includes the single-edged knife that incisesskin and soft tissue.

“Scalpet” as used herein includes the term that describes the smallgeometrically-shaped (e.g., circle, ellipse, rectangle, square, etc.)scalpel that incises a plug of skin.

“Scalpet Array” as used herein includes the arrangement or array ofmultiple scalpets secured to a substrate (e.g., a base plate, stamper,handled stamper, tip, disposable tip, etc.).

“Scalpet Stamper” as used herein includes a handled scalpet arrayinstrument component of the PAD Kit that incises skin plugs through theperforated guide plate.

“Scar” as used herein includes the histological deposition ofdisorganized collagen following wounding, or the morphological deformitythat is visually apparent from the histological deposition ofdisorganized collagen following wounding.

“Sheet Full Thickness Skin Graft” as used herein includes reference toapplication of the FTSG at the recipient site as continuous sheet. Theappearance of an FTSG is superior to the appearance of a STSG and forthis reason it is primarily used for skin grafting in visually apparentareas such as the face.

“Sheet Split Thickness Skin Graft” as used herein includes a partialthickness skin graft that is a continuous sheet and is associated withthe typical donor site deformity.

“Skin Defect” as used herein includes the absence of the full thicknessof skin that may also include the subcutaneous fat layer and deeperstructures such as muscle. Skin defects can occur from a variety ofcauses i.e., burns, trauma, surgical excision of malignancies and thecorrection of congenital deformities.

“Skin Pixel” as used herein includes a piece of skin comprisingepidermis and a partial or full thickness of the dermis that is cut bythe scalpet; the skin pixel may include skin adnexa such as a hairfollicle with or without a cuff of subcutaneous fat; also includes SkinPlug.

“Skin Plug” as used herein includes a circular (or other geometricshaped) piece of skin comprising epidermis and a partial or fullthickness of the dermis that is incised by the scalpet, transected bythe transection blade and captured by the adherent-backed membrane.

“STSG” as used herein includes the Partial Thickness Skin Graft in whichthe epidermis and a portion of the dermis is harvested with the graft.

“Subcutaneous Fat Layer” as used herein includes the layer that isimmediately below the skin and is principally comprised of fat cellsreferred to as lipocytes. This layer functions as principle insulationlayer from the environment.

“Transection Blade” as used herein includes a horizontally-alignedsingle edged blade that can be either slotted to the frame of theperforated plate or attached to the outrigger arm of the drum dermatomeas described in detail herein. The transection blade transects the baseof the incised skin plugs.

“Wound Healing” as used herein includes the obligate biological processthat occurs from any type of wounding whether it be one or more ofthermal, kinetic and surgical.

“Xenograft” as used herein includes a graft taken from a differentspecies and applied as a temporary biological dressing to a recipientsite on a patient.

Multiple embodiments of pixel array medical systems, instruments ordevices, and methods for use are described in detail herein. Thesystems, instruments or devices, and methods described herein compriseminimally invasive surgical approaches for skin grafting and for skinresection that tightens lax skin without visible scarring via a deviceused in various surgical procedures such as plastic surgery procedures,and additionally for hair transplantation. In some embodiments, thedevice is a single use disposable instrument. The embodiments hereincircumvent surgically related scarring and the clinical variability ofelectromagnetic heating of the skin and perform small multiple pixilatedresections of skin as a minimally invasive alternative to large plasticsurgical resections of skin. The embodiments herein can also be employedin hair transplantation, and in areas of the body that may be off limitsto plastic surgery due to the visibility of the surgical scar. Inaddition, the approach can perform a skin grafting operation byharvesting the transected incisions of skin from a tissue site of adonor onto a skin defect site of a recipient with reduced scarring ofthe patient's donor site.

For many patients who have age related skin laxity (for non-limitingexamples, neck and face, arms, axillas, thighs, knees, buttocks,abdomen, bra line, ptosis of the breast, etc.), the minimally invasivepixel array medical devices and methods herein perform pixilatedtransection/resection of excess skin, replacing plastic surgery with itsincumbent scarring. Generally, the procedures described herein areperformed in an office setting under a local anesthetic with minimalperioperative discomfort, but are not so limited. In comparison to aprolonged healing phase from plastic surgery, only a short recoveryperiod is required, preferably applying a dressing and a support garmentworn over the treatment area for a pre-specified period of time (e.g., 5days, 7 days, etc.). There will be minimal or no pain associated withthe procedure.

The relatively small (e.g., in a range of approximately 0.5 mm to 4.0mm) skin defects generated by the instrumentation described herein areclosed with the application of an adherent Flexan® sheet. Functioning asa large butterfly bandage, the Flexan® sheet can be pulled in adirection (“vector”) that maximizes the aesthetic contouring of thetreatment area. A compressive elastic garment is applied over thedressing to further assist aesthetic contouring. After completion of theinitial healing phase, the multiplicity of small linear scars within thetreatment area will have reduced visibility in comparison to largerplastic surgical incisions on the same area. Additional skin tighteningis likely to occur over several months due to the delayed wound healingresponse. Other potential applications of the embodiments describedherein include hair transplantation as well as the treatment ofAlopecia, Snoring/Sleep apnea, Orthopedics/Physiatry, VaginalTightening, Female Urinary incontinence, and tightening ofgastrointestinal sphincters.

Significant burns are classified by the total body surface burned and bythe depth of thermal destruction, and the methods used to manage theseburns depend largely on the classification. First-degree andsecond-degree burns are usually managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin, creating a full thickness skin defect. The surgical management ofthis serious injury usually involves the debridement of the burn escharand the application of split thickness grafts.

A full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using conventional commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts from thesame patient. Typically, the donor site on the burn patient is chosen ina non-burned area and a partial thickness sheet of skin is harvestedfrom that area. Incumbent upon this procedure is the creation of apartial thickness skin defect at the donor site. This donor site defectitself is similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity istypically created that is permanently thinner and more de-pigmented thanthe surrounding skin. For patients who have burns over a significantsurface area, the extensive harvesting of skin grafts may also belimited by the availability of non-burned areas.

Both conventional surgical approaches to close skin defects (flaptransfer and skin grafting) are not only associated with significantscarring of the skin defect recipient site but also with the donor sitefrom which the graft is harvested. In contrast to the conventionalprocedures, embodiments described herein comprise Pixel Skin GraftingProcedures, also referred to as a pixel array procedures, that eliminatethis donor site deformity and provide a method to re-harvest skin graftsfrom any pre-existing donor site including either sheet or pixelateddonor sites. This ability to re-harvest skin grafts from pre-existingdonor sites will reduce the surface area requirement for donor site skinand provide additional skin grafting capability in severely burnedpatients who have limited surface area of unburned donor skin.

The Pixel Skin Grafting Procedure of an embodiment is used as a fullthickness skin graft. Many clinical applications such as facial skingrafting, hand surgery, and the repair of congenital deformities arebest performed with full thickness skin grafts. The texture,pigmentation and overall morphology of a full thickness skin graft moreclosely resembles the skin adjacent to a defect than a split thicknessskin graft. For this reason, full thickness skin grafting in visiblyapparent areas is superior in appearance than split thickness skingrafts. The main drawback to full thickness skin grafts underconventional procedures is the extensive linear scarring created fromthe surgical closure of the full thickness donor site defect; thisscarring limits the size and utility of full thickness skin grafting.

In comparison, the full thickness skin grafting of the Pixel SkinGrafting Procedure described herein is less limited by size and utilityas the linear donor site scar is eliminated. Thus, many skin defectsroutinely covered with split thickness skin grafts will instead betreated using pixelated full thickness skin grafts.

The Pixel Skin Grafting Procedure provides the capability to harvestsplit thickness and full thickness skin grafts with minimal visiblescarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) device is used to harvest the skin graft from a chosendonor site. During the harvesting procedure, the pixilated skin graft isdeposited onto an adherent membrane. The adherent membrane of anembodiment includes a flexible, semi-porous, adherent membrane, but theembodiment is not so limited. The harvested skin graft/membranecomposite is then applied directly to the recipient skin defect site.The fractionally resected donor site is closed with the application ofan adherent Flexan® sheeting that functions for one week as a largebutterfly bandage. The relatively small (e.g., 1.5 mm) intradermalcircular skin defects are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring approximatelyone week postoperatively, the adherent membrane is desquamated (shed)with the stratum corneum of the graft; the membrane can then be removedwithout disruption of the graft from the recipient bed. Thus, healing ofthe donor site occurs rapidly with minimal discomfort and scarring.

Because the skin graft at the recipient defect site using the Pixel SkinGrafting Procedure is pixelated it provides interstices for drainagebetween skin pixel components, which enhances the percentage of “takes,”compared to sheet skin grafts. During the first post-operative week(approximate), the skin graft will “take” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semi-porousmembrane will conduct the transudate (fluid) into the dressing.Furthermore, the flexible membrane is designed with an elastic recoilproperty that promotes apposition of component skin pixels within thegraft/membrane composite and promotes primary adjacent healing of theskin graft pixels, converting the pixilated appearance of the skin graftto a uniform sheet morphology. Additionally, the membrane aligns themicro-architectural component skin pixels, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring. Moreover, pixelated skin grafts moreeasily conform to an irregular recipient site.

Embodiments described herein also include a Pixel Skin ResectionProcedure, also referred to herein as the Pixel Procedure. For manypatients who have age related skin laxity (neck and face, arms, axillas,thighs, knees, buttocks, abdomen, bra line, ptosis of the breast, etc.),fractional resection of excess skin could replace a significant segmentof plastic surgery with its incumbent scarring. Generally, the PixelProcedure will be performed in an office setting under a localanesthetic. The post procedure recovery period includes wearing of asupport garment over the treatment area for a pre-specified number(e.g., five, seven, etc.) of days (e.g., five days, seven days, etc.).Relatively little or no pain is anticipated to be associated with theprocedure. The small (e.g., 1.5 mm) circular skin defects will be closedwith the application of an adherent Flexan® sheet. Functioning as alarge butterfly bandage, the Flexan® sheet is pulled in a direction(“vector”) that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing tofurther assist aesthetic contouring. After completion of the initialhealing phase, the multiplicity of small linear scars within thetreatment area will not be visibly apparent. Furthermore, additionalskin tightening will subsequently occur over several months due to thedelayed wound healing response. Consequently, the Pixel Procedure is aminimally invasive alternative to the extensive scarring of PlasticSurgery.

The pixel array medical devices of an embodiment include a PAD Kit. FIG.1 shows the PAD Kit placed at a target site, under an embodiment. ThePAD Kit comprises a flat perforated guide plate (guide plate), a scalpetpunch or device that includes a scalpet array (FIGS. 1-3), a backedadhesive membrane or adherent substrate (FIG. 4), and a skin pixeltransection blade (FIG. 5), but is not so limited. The scalpet punch ofan embodiment is a handheld device but is not so limited. The guideplate is optional in an alternative embodiment, as described in detailherein.

FIG. 2 is a cross-section of a PAD Kit scalpet punch including a scalpetarray, under an embodiment. The scalpet array includes one or morescalpets. FIG. 3 is a partial cross-section of a PAD Kit scalpet punchincluding a scalpet array, under an embodiment. The partialcross-section shows the total length of the scalpets of the scalpetarray is determined by the thickness of the perforated guide plate andthe incisional depth into the skin, but the embodiment is not solimited.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment. The undersurface of theadhesive membrane is applied to the incised skin at the target site.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment. The topsurface of the adhesive membrane is oriented with the adhesive side downinside the frame and then pressed over the perforated plate to capturethe extruded skin pixels, also referred to herein as plugs or skinplugs.

With reference to FIG. 1, the perforated guide plate is applied to theskin resection/donor site during a procedure using the PAD Kit. Thescalpet punch is applied through at least a set of perforations of theperforated guide plate to incise the skin pixels. The scalpet punch isapplied numerous times to a number of sets of perforations when thescalpet array of the punch includes fewer scalpets then the total numberof perforations of the guide plate. Following one or more serialapplications with the scalpet punch, the incised skin pixels or plugsare captured onto the adherent substrate. The adherent substrate is thenapplied in a manner so the adhesive captures the extruded skin pixels orplugs. As an example, the top surface of the adherent substrate of anembodiment is oriented with the adhesive side down inside the frame(when the frame is used) and then pressed over the perforated plate tocapture the extruded skin pixels or plugs. As the membrane is pulled up,the captured skin pixels are transected at their base by the transectionblade.

FIG. 6 shows the removal of skin pixels, under an embodiment. Theadherent substrate is pulled up and back (away) from the target site,and this act lifts or pulls the incised skin pixels or plugs. As theadherent substrate is being pulled up, the transection blade is used totransect the bases of the incised skin pixels. FIG. 7 is a side view ofblade transection and removal of incised skin pixels with the PAD Kit,under an embodiment. Pixel harvesting is completed with the transectionof the base of the skin pixels or plugs. FIG. 8 is an isometric view ofblade/pixel interaction during a procedure using the PAD Kit, under anembodiment. FIG. 9 is another view during a procedure using the PAD Kit(blade removed for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment. At the donor site, the pixelated skinresection sites are closed with the application of Flexan® sheeting.

The guide plate and scalpet device are also used to generate skindefects at the recipient site. The skin defects are configured toreceive the skin pixels harvested or captured at the donor site. Theguide plate used at the recipient site can be the same guide plate usedat the donor site, or can be different with a different pattern orconfiguration of perforations.

The skin pixels or plugs deposited onto the adherent substrate duringthe transection can next be transferred to the skin defect site(recipient site) where they are applied as a pixelated skin graft at arecipient skin defect site. The adherent substrate has an elastic recoilproperty that enables closer alignment of the skin pixels or plugswithin the skin graft. The incised skin pixels can be applied from theadherent substrate directly to the skin defects at the recipient site.Application of the incised skin pixels at the recipient site includesaligning the incised skin pixels with the skin defects, and insertingthe incised skin pixels into corresponding skin defects at the recipientsite.

The pixel array medical devices of an embodiment include a Pixel ArrayDermatome (PAD). The PAD comprises a flat array of relatively smallcircular scalpets that are secured onto a substrate (e.g., investingplate), and the scalpets in combination with the substrate are referredto herein as a scalpet array, pixel array, or scalpet plate. FIG. 10A isa side view of a portion of the pixel array showing scalpets securedonto an investing plate, under an embodiment. FIG. 10B is a side view ofa portion of the pixel array showing scalpets secured onto an investingplate, under an alternative embodiment. FIG. 10C is a top view of thescalpet plate, under an embodiment. FIG. 10D is a close view of aportion of the scalpet plate, under an embodiment. The scalpet plate isapplied directly to the skin surface. One or more scalpets of thescalpet array include one or more of a pointed surface, a needle, and aneedle including multiple points.

Embodiments of the pixel array medical devices and methods include useof a harvest pattern instead of the guide plate. The harvest patterncomprises indicators or markers on a skin surface on at least one of thedonor site and the recipient site, but is not so limited. The markersinclude any compound that may be applied directly to the skin to mark anarea of the skin. The harvest pattern is positioned at a donor site, andthe scalpet array of the device is aligned with or according to theharvest pattern at the donor site. The skin pixels are incised at thedonor site with the scalpet array as described herein. The recipientsite is prepared by positioning the harvest pattern at the recipientsite. The harvest pattern used at the recipient site can be the sameharvest pattern used at the donor site, or can be different with adifferent pattern or configuration of markers. The skin defects aregenerated, and the incised skin pixels are applied at the recipient siteas described herein. Alternatively, the guide plate of an embodiment isused in applying the harvest pattern, but the embodiment is not solimited.

To leverage established surgical instrumentation, the array of anembodiment is used in conjunction with or as a modification to a drumdermatome, for example a Padget dermatome or a Reese dermatome, but isnot so limited. The Padget drum dermatome referenced herein wasoriginally developed by Dr. Earl Padget in the 1930s, and continues tobe widely utilized for skin grafting by plastic surgeons throughout theworld. The Reese modification of the Padget dermatome was subsequentlydeveloped to better calibrate the thickness of the harvested skin graft.The drum dermatome of an embodiment is a single use (per procedure)disposable, but is not so limited.

Generally, FIG. 11A shows an example of a rolling pixel drum 100, underan embodiment. FIG. 11B shows an example of a rolling pixel drum 100assembled on a handle, under an embodiment. More specifically, FIG. 11Cdepicts a drum dermatome for use with the scalpet plate, under anembodiment.

Generally, as with all pixel devices described herein, the geometry ofthe pixel drum 100 can be a variety of shapes without limitation e.g.,circular, semicircular, elliptical, square, flat, or rectangular. Insome embodiments, the pixel drum 100 is supported by an axel/handleassembly 102 and rotated around a drum rotational component 104 poweredby, e.g., an electric motor. In some embodiments, the pixel drum 100 canbe placed on stand (not shown) when not in use, wherein the stand canalso function as a battery recharger for the powered rotationalcomponent of the drum or the powered component of the syringe plunger.In some embodiments, a vacuum (not shown) can be applied to the skinsurface of the pixel drum 100 and outriggers (not shown) can be deployedfor tracking and stability of the pixel drum 100.

In some embodiments, the pixel drum 100 incorporates an array ofscalpets 106 on the surface of the drum 100 to create small multiple(e.g., 0.5-1.5 mm) circular incisions referred to herein as skin plugs.In some embodiments, the border geometry of the scalpets can be designedto reduce pin cushioning (“trap door”) while creating the skin plugs.The perimeter of each skin plug can also be lengthened by the scalpetsto, for a non-limiting example, a, semicircular, elliptical, orsquare-shaped skin plug instead of a circular-shaped skin plug. In someembodiments, the length of the scalpets 106 may vary depending upon thethickness of the skin area selected by the surgeon for skin graftingpurposes, i.e., partial thickness or full thickness.

When the drum 100 is applied to a skin surface, a blade 108 placedinternal of the drum 100 transects the base of each skin plug created bythe array of scalpets, wherein the internal blade 108 is connected tothe central drum axel/handle assembly 102 and/or connected to outriggersattached to the central axel assembly 102. In some alternativeembodiments, the internal blade 108 is not connected to the drum axelassembly 102 where the base of the incisions of skin is transected. Insome embodiments, the internal blade 108 of the pixel drum 100 mayoscillate either manually or be powered by an electric motor. Dependingupon the density of the circular scalpets on the drum, a variablepercentage of skin (e.g., 20%, 30%, 40%, etc.) can be transected withinan area of excessive skin laxity.

In some embodiments, an added pixel drum harvester 112 is placed insidethe drum 100 to perform a skin grafting operation by harvesting andaligning the transected/pixilated skin incisions/plugs (pixel graft)from tissue of a pixel donor onto an adherent membrane 110 lined in theinterior of the pixel drum 100. A narrow space is created between thearray of scalpets 106 and the adherent membrane 110 for the internalblade 108.

In an embodiment, the blade 108 is placed external to the drum 100 andthe scalpet array 106 where the base of the incised circular skin plugsis transected. In another embodiment, the external blade 108 isconnected to the drum axel assembly 102 when the base of the incisionsof skin is transected. In an alternative embodiment, the external blade108 is not connected to the drum axel assembly 102 when the base of theincisions of skin is transected. The adherent membrane 110 that extractsand aligns the transected skin segments is subsequently placed over askin defect site of a patient. The blade 108 (either internal orexternal) can be a fenestrated layer of blade aligned to the scalpetarray 106, but is not so limited.

The conformable adherent membrane 110 of an embodiment can besemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned transected skin segments is extracted from thedrum and applied as a skin graft. The adherent semi-porous drum membrane110 can also have an elastic recoil property to bring thetransected/pixilated skin plugs together for grafting onto the skindefect site of the recipient, i.e., the margins of each skin plug can bebrought closer together as a more uniform sheet after the adherentmembrane with pixilated grafts extracted from the drum 100.Alternatively, the adherent semi-porous drum membrane 110 can beexpandable to cover a large surface area of the skin defect site of therecipient. In some embodiments, a sheet of adhesive backer 111 can beapplied between the adherent membrane 110 and the drum harvester 112.The drum array of scalpets 106, blade 108, and adherent membrane 110 canbe assembled together as a sleeve onto a preexisting drum 100, asdescribed in detail herein.

The internal drum harvester 112 of the pixel drum 110 of an embodimentis disposable and replaceable. Limit and/or control the use of thedisposable components can be accomplished by means that includes but isnot limited to electronic, EPROM, mechanical, durability. The electronicand/or mechanical records and/or limits of number of drum rotations forthe disposable drum as well as the time of use for the disposable drumcan be recorded, controlled and/or limited either electronically ormechanically.

During the harvesting portion of the procedure with a drum dermatome,the PAD scalpet array is applied directly to the skin surface. Tocircumferentially incise the skin pixels, the drum dermatome ispositioned over the scalpet array to apply a load onto the subjacentskin surface. With a continuing load, the incised skin pixels areextruded through the holes of the scalpet array and captured onto anadherent membrane on the drum dermatome. The cutting outrigger blade ofthe dermatome (positioned over the scalpet array) transects the base ofextruded skin pixels. The membrane and the pixelated skin composite arethen removed from the dermatome drum, to be directly applied to therecipient skin defect as a skin graft.

With reference to FIG. 11C, an embodiment includes a drum dermatome foruse with the scalpet plate, as described herein. More particularly, FIG.12A shows the drum dermatome positioned over the scalpet plate, under anembodiment. FIG. 12B is an alternative view of the drum dermatomepositioned over the scalpet plate, under an embodiment. The cuttingoutrigger blade of the drum dermatome is positioned on top of thescalpet array where the extruded skin plugs will be transected at theirbase.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment. FIG. 13B is a side view of aportion of the drum dermatome showing a blade position relative to thescalpet plate, under an embodiment. FIG. 13C is a side view of theportion of the drum dermatome showing a different blade positionrelative to the scalpet plate, under an embodiment. FIG. 13D is a sideview of the drum dermatome with another blade position relative to thescalpet plate, under an embodiment. FIG. 13E is a side view of the drumdermatome with the transection blade clip showing transection of skinpixels by the blade clip, under an embodiment. FIG. 13F is a bottom viewof the drum dermatome along with the scalpet plate, under an embodiment.FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment. FIG. 13H is a back view of the drumdermatome along with the scalpet plate, under an embodiment.

Depending upon the clinical application, the disposable adherentmembrane of the drum dermatome can be used to deposit/dispose ofresected lax skin or harvest/align a pixilated skin graft.

Embodiments described herein also include a Pixel Onlay Sleeve (POS) foruse with the dermatomes, for example the Padget dermatomes and Reesedermatomes. FIG. 14A shows an assembled view of the dermatome with thePixel Onlay Sleeve (POS), under an embodiment. The POS comprises thedermatome and blade incorporated with an adhesive backer, adhesive, anda scalpet array. The adhesive backer, adhesive, and scalpet array areintegral to the device, but are not so limited. FIG. 14B is an explodedview of the dermatome with the Pixel Onlay Sleeve (POS), under anembodiment. FIG. 14C shows a portion of the dermatome with the PixelOnlay Sleeve (POS), under an embodiment.

The POS, also referred to herein as the “sleeve,” provides a disposabledrum dermatome onlay for the fractional resection of redundant lax skinand the fractional skin grafting of skin defects. The onlay sleeve isused in conjunction with either the Padget and Reese dermatomes as asingle use disposable component. The POS of an embodiment is athree-sided slip-on disposable sleeve that slips onto a drum dermatome.The device comprises an adherent membrane and a scalpet drum array withan internal transection blade. The transection blade of an embodimentincludes a single-sided cutting surface that sweeps across the internalsurface of the scalpet drum array.

In an alternative blade embodiment, a fenestrated cutting layer coversthe internal surface of the scalpet array. Each fenestration with itscutting surface is aligned with each individual scalpet. Instead ofsweeping motion to transect the base of the skin plugs, the fenestratedcutting layer oscillates over the scalpet drum array. A narrow spacebetween the adherent membrane and the scalpet array is created forexcursion of the blade. For multiple harvesting during a skin graftingprocedure, an insertion slot for additional adherent membranes isprovided. The protective layer over the adherent membrane is pealed awayinsitu with an elongated extraction tab that is pulled from anextraction slot on the opposite side of the sleeve assembly. As withother pixel device embodiments, the adherent membrane is semi-porous fordrainage at the recipient skin defect site. To morph the pixilated skingraft into a more continuous sheet, the membrane may also have anelastic recoil property to provide closer alignment of the skin plugswithin the skin graft.

Embodiments described herein include a Slip-On PAD that is configured asa single-use disposable device with either the Padgett or Reesedermatomes. FIG. 15A shows the Slip-On PAD being slid onto a PadgettDrum Dermatome, under an embodiment. FIG. 15B shows an assembled view ofthe Slip-On PAD installed over the Padgett Drum Dermatome, under anembodiment.

The Slip-on PAD of an embodiment is used (optionally) in combinationwith a perforated guide plate. FIG. 16A shows the Slip-On PAD installedover a Padgett Drum Dermatome and used with a perforated template orguide plate, under an embodiment. The perforated guide plate is placedover the target skin site and held in place with adhesive on the bottomsurface of the apron to maintain orientation. The Padgett Dermatome withSlip-On PAD is rolled over the perforated guide plate on the skin.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment. For skin pixel harvesting,the Slip-On PAD is removed, adhesive tape is applied over the drum ofthe Padgett dermatome, and the clip-on blade is installed on theoutrigger arm of the dermatome, which then is used to transect the baseof the skin pixels. The Slip-on PAD of an embodiment is also used(optionally) with standard surgical instrumentation such as a ribbonretractor to protect the adjacent skin of the donor site.

Embodiments of the pixel instruments described herein include a PixelDrum Dermatome (PD2) that is a single use disposable instrument ordevice. The PD2 comprises a cylinder or rolling/rotating drum coupled toa handle, and the cylinder includes a Scalpet Drum Array. An internalblade is interlocked to the drum axle/handle assembly and/or interlockedto outriggers attached to the central axle. As with the PAD and the POSdescribed herein, small multiple pixilated resections of skin areperformed directly in the region of skin laxity, thereby enhancing skintightening with minimal visible scarring.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment. FIG. 17B shows analternative view of a portion of the Pixel Drum Dermatome being appliedto a target site of the skin surface, under an embodiment.

The PD2 device applies a full rolling/rotating drum to the skin surfacewhere multiple small (e.g., 1.5 mm) circular incisions are created atthe target site with a “Scalpet Drum Array”. The base of each skin plugis then transected with an internal blade that is interlocked to thecentral drum axel/handle assembly and/or interlocked to outriggersattached to the central axel. Depending upon the density of the circularscalpets on the drum, a variable percentage of skin can be resected. ThePD2 enables portions (e.g., 20%, 30%, 40%, etc.) of the skin's surfacearea to be resected without visible scarring in an area of excessiveskin laxity, but the embodiment is not so limited.

Another alternative embodiment of the pixel instruments presented hereinis the Pixel Drum Harvester (PDH). Similar to the Pixel Drum Dermatome,an added internal drum harvests and aligns the pixilated resections ofskin onto an adherent membrane that is then placed over a recipient skindefect site of the patient. The conformable adherent membrane issemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned resected skin segments is extracted from thedrum and applied as a skin graft. An elastic recoil property of themembrane allows closer approximation of the pixilated skin segments,partially converting the pixilated skin graft to a sheet graft at therecipient site.

The pixel array medical systems, instruments or devices, and methodsdescribed herein evoke or enable cellular and/or extracellular responsesthat are obligatory to the clinical outcomes achieved. For the pixeldermatomes, a physical reduction of the skin surface area occurs due tothe pixilated resection of skin, i.e., creation of the skin plugs. Inaddition, a subsequent tightening of the skin results due to the delayedwound healing response. Each pixilated resection initiates an obligatewound healing sequence in multiple phases as described in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells release histamine into the “wound”.Histamine release may evoke dilatation of the capillary bed and increasevessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

The second phase (of Fibroplasia) commences within three to four days of“wounding”. During this phase, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia of the wound includes thedeposition of neocollagen and the myofibroblastic contraction of thewound.

Histologically, the deposition of neocollagen can be identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the woundsignificantly increases. The other feature of Fibroplasia is a dynamicphysical process that results in a multi-dimensional contraction of thewound. This component feature of Fibroplasia is due to the activecellular contraction of myofibroblasts. Morphologically, myoblasticcontraction of the wound will be visualized as a two dimensionaltightening of the skin surface. Overall, the effect of Fibroplasia isdermal contraction along with the deposition of a static supportingscaffolding of neocollagen with a tightened framework. The clinicaleffect is seen as a delayed tightening of skin with smoothing of skintexture over several months. The clinical endpoint is generally a moreyouthful appearing skin envelope of the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During this phase there is a strengthening and remodeling ofthe treatment area due to an increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within six totwelve months after “wounding” and may extend for at least one to twoyears. Small pixilated resections of skin should preserve the normaldermal architecture during this delayed wound healing process withoutthe creation of an evident scar that typically occurs with a largersurgical resection of skin. Lastly, there is a related stimulation andrejuvenation of the epidermis from the release of epidermal growthhormone. The delayed wound healing response can be evoked, with scarcollagen deposition, within tissues (such as muscle or fat) with minimalpre-existing collagen matrix.

Other than tightening skin for aesthetic purposes, the pixel arraymedical systems, instruments or devices, and methods described hereinmay have additional medically related applications. In some embodiments,the pixel array devices can transect a variable portion of any softtissue structure without resorting to a standard surgical resection.More specifically, the reduction of an actinic damaged area of skin viathe pixel array devices should reduce the incidence of skin cancer. Forthe treatment of sleep apnea and snoring, a pixilated mucosal reduction(soft palate, base of the tongue and lateral pharyngeal walls) via thepixel array devices would reduce the significant morbidity associatedwith more standard surgical procedures. For birth injuries of thevaginal vault, pixilated skin and vaginal mucosal resection via thepixel array devices would reestablish normal pre-partum geometry andfunction without resorting to an A&P resection. Related female stressincontinence could also be corrected in a similar fashion.

The pixel array dermatome (PAD) of an embodiment, also referred toherein as a scalpet device assembly, includes a system or kit comprisinga control device, also referred to as a punch impact hand-piece, and ascalpet device, also referred to as a tip device. The scalpet device,which is removeably coupled to the control device, includes an array ofscalpets positioned within the scalpet device. The removeable scalpetdevice of an embodiment is disposable and consequently configured foruse during a single procedure, but the embodiment is not so limited.

The PAD includes an apparatus comprising a housing configured to includea scalpet device. The scalpet device includes a substrate and a scalpetarray, and the scalpet array includes a plurality of scalpets arrangedin a configuration on the substrate. The substrate and the plurality ofscalpets are configured to be deployed from the housing and retractedinto the housing, and the plurality of scalpets is configured togenerate a plurality of incised skin pixels at a target site whendeployed. The proximal end of the control device is configured to behand-held. The housing is configured to be removeably coupled to areceiver that is a component of a control device. The control deviceincludes a proximal end that includes an actuator mechanism, and adistal end that includes the receiver. The control device is configuredto be disposable, but alternatively the control device is configured tobe at least one of cleaned, disinfected, and sterilized.

The scalpet array is configured to be deployed in response to activationof the actuator mechanism. The scalpet device of an embodiment isconfigured so the scalpet array is deployed from the scalpet device andretracted back into the scalpet device in response to activation of theactuator mechanism. The scalpet device of an alternative embodiment isconfigured so the scalpet array is deployed from the scalpet device inresponse to activation of the actuator mechanism, and retracted backinto the scalpet device in response to release of the actuatormechanism.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment. The PAD assembly of this embodiment includes a controldevice configured to be hand-held, with an actuator or trigger and thescalpet device comprising the scalpet array. The control device isreusable, but alternative embodiments include a disposable controldevice. The scalpet array of an embodiment is configured to create orgenerate an array of incisions (e.g., 1.5 mm, 2 mm, 3 mm, etc.) asdescribed in detail herein. The scalpet device of an embodiment includesa spring-loaded array of scalpets configured to incise the skin asdescribed in detail herein, but the embodiments are not so limited.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment. FIG. 19B shows a bottomperspective view of the scalpet device for use with the PAD assembly,under an embodiment. The scalpet device comprises a housing configuredto house a substrate that is coupled to or includes a plunger. Thehousing is configured so that a proximal end of the plunger protrudesthrough a top surface of the housing. The housing is configured to beremoveably coupled to the control device, and a length of the plunger isconfigured to protrude a distance through the top surface to contact thecontrol device and actuator when the scalpet device is coupled to thecontrol device.

The substrate of the scalpet device is configured to retain numerousscalpets that form the scalpet array. The scalpet array comprises apre-specified number of scalpets as appropriate to the procedure inwhich the scalpet device assembly is used. The scalpet device includesat least one spring mechanism configured to provide a downward, orimpact or punching, force in response to activation of the scalpet arraydevice, and this force assists generation of incisions (pixelated skinresection sites) by the scalpet array. Alternatively, the springmechanism can be configured to provide an upward, or retracting, forceto assist in retraction of the scalpet array.

One or more of the scalpet device and the control device of anembodiment includes an encryption system (e.g., EPROM, etc.). Theencryption system is configured to prevent illicit use and pirating ofthe scalpet devices and/or control devices, but is not so limited.

During a procedure, the scalpet device assembly is applied one time to atarget area or, alternative, applied serially within a designated targettreatment area of skin laxity. The pixelated skin resection sites withinthe treatment area are then closed with the application of Flexansheeting, as described in detail herein, and directed closure of thesepixelated resections is performed in a direction that provides thegreatest aesthetic correction of the treatment site.

The PAD device of an alternative embodiment includes a vacuum componentor system for removing incised skin pixels. FIG. 20 shows a side view ofthe punch impact device including a vacuum component, under anembodiment. The PAD of this example includes a vacuum system orcomponent within the control device to suction evacuate the incised skinpixels, but is not so limited. The vacuum component is removeablycoupled to the PAD device, and its use is optional. The vacuum componentis coupled to and configured to generate a low-pressure zone within oradjacent to one or more of the housing, the scalpet device, the scalpetarray, and the control device. The low-pressure zone is configured toevacuate the incised skin pixels.

The PAD device of another alternative embodiment includes a radiofrequency (RF) component or system for generating skin pixels. The RFcomponent is coupled to and configured to provide or couple energywithin or adjacent to one or more of the housing, the scalpet device,the scalpet array, and the control device. The RF component isremoveably coupled to the PAD device, and its use is optional. Theenergy provided by the RF component includes one or more of thermalenergy, vibrational energy, rotational energy, and acoustic energy, toname a few.

The PAD device of yet another alternative embodiment includes a vacuumcomponent or system and an RF component or system. The PAD of thisembodiment includes a vacuum system or component within the handpiece tosuction evacuate the incised skin pixels. The vacuum component isremoveably coupled to the PAD device, and its use is optional. Thevacuum component is coupled to and configured to generate a low-pressurezone within or adjacent to one or more of the housing, the scalpetdevice, the scalpet array, and the control device. The low-pressure zoneis configured to evacuate the incised skin pixels. Additionally, the PADdevice includes an RF component coupled to and configured to provide orcouple energy within or adjacent to one or more of the housing, thescalpet device, the scalpet array, and the control device. The RFcomponent is removeably coupled to the PAD device, and its use isoptional. The energy provided by the RF component includes one or moreof thermal energy, vibrational energy, rotational energy, and acousticenergy, to name a few.

As one particular example, the PAD of an embodiment includes anelectrosurgical generator configured to more effectively incise donorskin or skin plugs with minimal thermo-conductive damage to the adjacentskin. For this reason, the RF generator operates using relatively highpower levels with relatively short duty cycles, for example. The RFgenerator is configured to supply one or more of a powered impactorcomponent configured to provide additional compressive force forcutting, cycling impactors, vibratory impactors, and an ultrasonictransducer.

The PAD with RF of this example also includes a vacuum component, asdescribed herein. The vacuum component of this embodiment is configuredto apply a vacuum that pulls the skin up towards the scalpets (e.g.,into the lumen of the scalpets, etc.) to stabilize and promote the RFmediated incision of the skin within the fractional resection field, butis not so limited. One or more of the RF generator and the vacuumappliance is coupled to be under the control of a processor running asoftware application. Additionally, the PAD of this embodiment can beused with the guide plate as described in detail herein, but is not solimited.

In addition to fractional incision at a donor site, fractional skingrafting includes the harvesting and deposition of skin plugs (e.g.,onto an adherent membrane, etc.) for transfer to a recipient site. Aswith fractional skin resection, the use of a duty-driven RF cutting edgeon an array of scalpets facilitates incising donor skin plugs. The baseof the incised scalpets is then transected and harvested as described indetail herein.

The timing of the vacuum assisted component is processor controlled toprovide a prescribed sequence with the RF duty cycle. With softwarecontrol, different variations are possible to provide the optimalsequence of combined RF cutting with vacuum assistance. Withoutlimitation, these include an initial period of vacuum prior to the RFduty cycle. Subsequent to the RF duty cycle, a period during thesequence of an embodiment includes suction evacuation of the incisedskin plugs.

Other potential control sequences of the PAD include without limitationsimultaneous duty cycles of RF and vacuum assistance. Alternatively, acontrol sequence of an embodiment includes pulsing or cycling of the RFduty cycle within the sequence and/or with variations of RF power or theuse of generators at different RF frequencies.

Another alternative control sequence includes a designated RF cycleoccurring at the depth of the fractional incision. A lower power longerduration RF duty cycle with insulated shaft with an insulated shaft anactive cutting tip could generate a thermal-conductive lesion in thedeep dermal/subcutaneous tissue interface. The deep thermal lesion wouldevoke a delayed wound healing sequence that would secondarily tightenthe skin without burning of the skin surface.

With software control, different variations are possible to provide theoptimal sequence of combined RF cutting and powered mechanical cuttingwith vacuum assistance. Examples include but are not limited tocombinations of powered mechanical cutting with vacuum assistance, RFcutting with powered mechanical cutting and vacuum assistance, RFcutting with vacuum assistance, and RF cutting with vacuum assistance.Examples of combined software controlled duty cycles include but are notlimited to precutting vacuum skin stabilization period, RF cutting dutycycle with vacuum skin stabilization period, RF cutting duty cycle withvacuum skin stabilization and powered mechanical cutting period, poweredmechanical cutting with vacuum skin stabilization period, post cuttingRF duty cycle for thermal conductive heating of the deeper dermal and/orsubdermal tissue layer to evoke a wound healing response for skintightening, and a post cutting vacuum evacuation period for skintightening.

Another embodiment of pixel array medical devices described hereinincludes a device comprising an oscillating flat array of scalpets andblade either powered electrically or deployed manually (unpowered) andused for skin tightening as an alternative to the drum/cylinderdescribed herein. FIG. 21A shows a top view of an oscillating flatscalpet array and blade device, under an embodiment. FIG. 21B shows abottom view of an oscillating flat scalpet array and blade device, underan embodiment. Blade 108 can be a fenestrated layer of blade aligned tothe scalpet array 106. The instrument handle 102 is separated from theblade handle 103 and the adherent membrane 110 can be peeled away fromthe adhesive backer 111. FIG. 21C is a close-up view of the flat arraywhen the array of scalpets 106, blades 108, adherent membrane 110 andthe adhesive backer 111 are assembled together, under an embodiment. Asassembled, the flat array of scalpets can be metered to provide auniform harvest or a uniform resection. In some embodiments, the flatarray of scalpets may further include a feeder component 115 for theadherent harvesting membrane 110 and adhesive backer 111. FIG. 21D is aclose-up view of the flat array of scalpets with a feeder component 115,under an embodiment.

In another skin grafting embodiment, the pixel graft is placed onto anirradiated cadaver dermal matrix (not shown). When cultured onto thedermal matrix, a graft of full thickness skin is created for the patientthat is immunologically identical to the pixel donor. In embodiments,the cadaver dermal matrix can also be cylindrical transected similar insize to the harvested skin pixel grafts to provide histologicalalignment of the pixilated graft into the cadaver dermal framework. FIG.22 shows a cadaver dermal matrix cylindrically transected similar insize to the harvested skin pixel grafts, under an embodiment. In someembodiments, the percentage of harvest of the donor site can bedetermined in part by the induction of a normal dermal histology at theskin defect site of the recipient, i.e., a normal (smoother) surfacetopology of the skin graft is facilitated. With either the adherentmembrane or the dermal matrix embodiment, the pixel drum harvesterincludes the ability to harvest a large surface area for grafting withvisible scarring of the patient's donor site significantly reduced oreliminated.

In addition to the pixel array medical devices described herein,embodiments include drug delivery devices. For the most part, theparenteral delivery of drugs is still accomplished from an injectionwith a syringe and needle. To circumvent the negative features of theneedle and syringe system, the topical absorption of medicationtranscutaneously through an occlusive patch was developed. However, bothof these drug delivery systems have significant drawbacks. The humanaversion to a needle injection has not abated during the nearly twocenturies of its use. The variable systemic absorption of either asubcutaneous or intramuscular drug injection reduces drug efficacy andmay increase the incidence of adverse patient responses. Depending uponthe lipid or aqueous carrier fluid of the drug, the topically appliedocclusive patch is plagued with variable absorption across an epidermalbarrier. For patients who require local anesthesia over a large surfacearea of skin, neither the syringe/needle injections nor topicalanesthetics are ideal. The syringe/needle “field” injections are oftenpainful and may instill excessive amounts of the local anesthetic thatmay cause systemic toxicity. Topical anesthetics rarely provide thelevel of anesthesia required for skin related procedures.

FIG. 23 is a drum array drug delivery device 200, under an embodiment.The drug delivery device 200 successfully addresses the limitations anddrawbacks of other drug delivery systems. The device comprises adrum/cylinder 202 supported by an axel/handle assembly 204 and rotatedaround a drum rotation component 206. The handle assembly 204 of anembodiment further includes a reservoir 208 of drugs to be delivered anda syringe plunger 210. The surface of the drum 202 is covered by anarray of needles 212 of uniform length, which provide a uniformintradermal (or subdermal) injection depth with a more controlled volumeof the drug injected into the skin of the patient. During operation, thesyringe plunger 210 pushes the drug out of the reservoir 208 to beinjected into a sealed injection chamber 214 inside the drum 202 viaconnecting tube 216. The drug is eventually delivered into the patient'sskin at a uniform depth when the array of needles 212 is pushed into apatient's skin until the surface of the drum 202 hits the skin.Non-anesthetized skip area is avoided and a more uniform pattern ofcutaneous anesthesia is created. The rolling drum application of thedrug delivery device 200 also instills the local anesthetic faster withless discomfort to the patient.

FIG. 24A is a side view of a needle array drug delivery device 300,under an embodiment. FIG. 24B is an upper isometric view of a needlearray drug delivery device 300, under an embodiment. FIG. 24C is a lowerisometric view of a needle array drug delivery device 300, under anembodiment. The drug delivery device 300 comprises a flat array of fineneedles 312 of uniform length positioned on manifold 310 can be utilizedfor drug delivery. In this example embodiment, syringe 302 in which drugfor injection is contained can be plugged into a disposable adaptor 306with handles, and a seal 308 can be utilized to ensure that the syringe302 and the disposable adaptor 306 are securely coupled to each other.When the syringe plunger 304 is pushed, drug contained in syringe 302 isdelivered from syringe 302 into the disposable adaptor 306. The drug isfurther delivered into the patient's skin through the flat array of fineneedles 312 at a uniform depth when the array of needles 312 is pushedinto a patient's skin until manifold 310 hits the skin.

The use of the drug delivery device 200 may have as many clinicalapplications as the number of pharmacological agents that requiretranscutaneous injection or absorption. For non-limiting examples, a fewof the potential applications are the injection of local anesthetics,the injection of neuromodulators such as Botulinum toxin (Botox), theinjection of insulin and the injection of replacement estrogens andcorticosteroids.

In some embodiments, the syringe plunger 210 of the drug delivery device200 can be powered by, for a non-limiting example, an electric motor. Insome embodiments, a fluid pump (not shown) attached to an IV bag andtubing can be connected to the injection chamber 214 and/or thereservoir 208 for continuous injection. In some embodiments, the volumeof the syringe plunger 210 in the drug delivery device 200 is calibratedand programmable.

Another application of pixel skin graft harvesting with the PAD (PixelArray Dermatome) device as described in detail herein is Alopecia.Alopecia is a common aesthetic malady, and it occurs most frequently inthe middle-aged male population, but is also observed in the aging babyboomer female population. The most common form of alopecia is MalePattern Baldness (MPB) that occurs in the frontal-parietal region of thescalp. Male pattern baldness is a sex-linked trait that is transferredby the X chromosome from the mother to male offspring. For men, only onegene is needed to express this phenotype. As the gene is recessive,female pattern baldness requires the transfer of both X linked genesfrom both mother and father. Phenotypic penetrance can vary from patientto patient and is most frequently expressed in the age of onset and theamount of frontal/partial/occipital alopecia. The patient variability inthe phenotypic expression of MPB is due to the variable genotypictranslation of this sex-linked trait. Based upon the genotypicoccurrence of MPB, the need for hair transplantation is vast. Othernon-genetic related etiologies are seen in a more limited segment of thepopulation. These non-genetic etiologies include trauma, fungalinfections, lupus erythematosus, radiation and chemotherapy.

A large variety of treatment options have been proposed to the public.These include FDA approved topical medications such as Minoxidil andFinasteride which have had limited success as these agents require theconversion of dormant hair follicles into an anagen growth phase. Otherremedies include hairpieces and hair weaving. The standard of practiceremains surgical hair transplantation, which involves the transfer ofhair plugs, strips and flaps from the hair-bearing scalp into the nonhair-bearing scalp. For the most part, conventional hair transplantationinvolves the transfer of multiple single hair micrographs from thehair-bearing scalp to the non hair-bearing scalp of the same patient.Alternately, the donor plugs are initially harvested as hair strips andthen secondarily sectioned into micrographs for transfer to therecipient scalp. Regardless, this multi-staged procedure is both tediousand expensive, involving several hours of surgery for the averagepatient.

The conventional hair transplantation market has been encumbered bylengthy hair grafting procedures that are performed in several stages. Atypical hair grafting procedure involves the transfer of hair plugs froma donor site in the occipital scalp to a recipient site in the baldingfrontal-parietal scalp. For most procedures, each hair plug istransferred individually to the recipient scalp. Several hundred plugsmay be transplanted during a procedure that may require several hours toperform. Post procedure “take” or viability of the transplanted hairplugs is variable due to factors that limit neovascularization at therecipient site. Bleeding and mechanical disruption due to motion are keyfactors that reduce neovascularization and “take” of hair grafts.Embodiments described herein include surgical instrumentation configuredto transfer several hair grafts at once that are secured and aligned enmasse at a recipient site on the scalp. The procedures described hereinusing the PAD of an embodiment reduce the tedium and time required withconventional instrumentation.

FIG. 25 shows the composition of human skin. Skin comprises twohorizontally stratified layers, referred to as the epidermis and thedermis, acting as a biological barrier to the external environment. Theepidermis is the enveloping layer and comprises a viable layer ofepidermal cells that migrate upward and “mature” into a nonviable layercalled the stratum corneum. The stratum corneum is a lipid-keratincomposite that serves as a primary biological barrier, and this layer iscontinually shed and reconstituted in a process called desquamation. Thedermis is the subjacent layer that is the main structural support of theskin, and is predominately extracellular and is comprised of collagenfibers.

In addition to the horizontally stratified epidermis and dermis, theskin includes vertically-aligned elements or cellular appendagesincluding the pilosebaceous units, comprising the hair folical andsebacious gland. Pilosebaceous units each include a sebaceous oil glandand a hair follicle. The sebaceous gland is the most superficial anddischarges sebum (oil) into the shaft of the hair follicle. The base ofthe hair follicle is called the bulb and the base of the bulb has a deepgenerative component called the dermal papilla. The hair follicles aretypically aligned at an oblique angle to the skin surface. Hairfollicles in a given region of the scalp are aligned parallel to eachother. Although pilosebaceous units are common throughout the entireintegument, the density and activity of these units within a region ofthe scalp is a key determinate as to the overall appearance of hair.

In additional to pilosebaceous units, sweat glands also coursevertically through the skin. They provide a water-based transudate thatassists in thermoregulation. Apocrine sweat glands in the axilla andgroin express a more pungent sweat that is responsible for body odor.For the rest of the body, eccrine sweat glands excrete a less pungentsweat for thermoregulation.

Hair follicles proceed through different physiological cycles of hairgrowth. FIG. 26 shows the physiological cycles of hair growth. Thepresence of testosterone in a genetically-prone man will producealopecia to a variable degree in the frontal-parietal scalp.Essentially, the follicle becomes dormant by entering the telogen phasewithout return to the anagen phase. Male Pattern Baldness occurs whenthe hair fails to return from the telogen phase to the anagen phase.

The PAD of an embodiment is configured for en-masse harvesting ofhair-bearing plugs with en-masse transplantation of hair bearing plugsinto non hair-bearing scalp, which truncates conventional surgicalprocedures of hair transplantation. Generally, the devices, systemsand/or methods of an embodiment are used to harvest and align a largemultiplicity of small hair bearing plugs in a single surgical step orprocess, and the same instrumentation is used to prepare the recipientsite by performing a multiple pixelated resection of non hair-bearingscalp. The multiple hair-plug graft is transferred and transplanteden-masse to the prepared recipient site. Consequently, through use of anabbreviated procedure, hundreds of hair bearing plugs can be transferredfrom a donor site to a recipient site. Hair transplantation using theembodiments described herein therefore provides a solution that is asingle surgical procedure having ease, simplicity and significant timereduction over the tedious and multiple staged conventional process.

Hair transplantation using the pixel dermatome of an embodimentfacilitates improvements in the conventional standard follicular unitextraction (FUT) hair transplant approach. Generally, under theprocedure of an embodiment hair follicles to be harvested are taken fromthe Occipital scalp of the donor. In so doing, the donor site hair ispartially shaved, and the perforated plate of an embodiment is locatedon the scalp and oriented to provide a maximum harvest. FIG. 27 showsharvesting of donor follicles, under an embodiment. The scalpets in thescalpet array are configured to penetrate down to the subcutaneous fatlater to capture the hair follicle. Once the hair plugs are incised,they are harvested onto an adhesive membrane by transecting the base ofthe hair plug with the transection blade, as described in detail herein.Original alignment of the hair plugs with respect to each other at thedonor site is maintained by applying the adherent membrane beforetransecting the base. The aligned matrix of hair plugs on the adherentmembrane will then be grafted en masse to a recipient site on thefrontal-parietal scalp of the recipient.

FIG. 28 shows preparation of the recipient site, under an embodiment.The recipient site is prepared by resection of non-hair bearing skinplugs in a topographically identical pattern as the harvested occipitalscalp donor site. The recipient site is prepared for the mass transplantof the hair plugs using the same instrumentation that was used at thedonor site under an embodiment and, in so doing, scalp defects arecreated at the recipient site. The scalp defects created at therecipient site have the same geometry as the harvested plugs on theadherent membrane.

The adherent membrane laden with the harvested hair plugs is appliedover the same pattern of scalp defects at the recipient site.Row-by-row, each hair-bearing plug is inserted into its mirror imagerecipient defect. FIG. 29 shows placement of the harvested hair plugs atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

More particularly, the donor site hair is partially shaved to preparefor location or placement of the perforated plate on the scalp. Theperforated plate is positioned on the occipital scalp donor site toprovide a maximum harvest. FIG. 30 shows placement of the perforatedplate on the occipital scalp donor site, under an embodiment. Massharvesting of hair plugs is achieved using the spring-loaded pixilationdevice comprising the impact punch hand-piece with a scalpet disposabletip. An embodiment is configured for harvesting of individual hair plugsusing off-the-shelf FUE extraction devices or biopsy punches; the holesin the perforated plates supplied are sized to accommodate off-the-shelftechnology.

The scalpets comprising the scalpet array disposable tip are configuredto penetrate down to the subcutaneous fat later to capture the hairfollicle. FIG. 31 shows scalpet penetration depth through skin when thescalpet is configured to penetrate to the subcutaneous fat layer tocapture the hair follicle, under an embodiment. Once the hair plugs areincised, they are harvested onto an adhesive membrane by transecting thebase of the hair plug with the transection blade, but are not solimited. FIG. 32 shows hair plug harvesting using the perforated plateat the occipital donor site, under an embodiment. The original alignmentof the hair plugs with respect to each other is maintained by applyingan adherent membrane of an embodiment. The adherent membrane is appliedbefore transecting the base of the resected pixels, the embodiments arenot so limited. The aligned matrix of hair plugs on the adherentmembrane is subsequently grafted en masse to a recipient site on thefrontal-parietal scalp.

Additional single hair plugs may be harvested through the perforatedplate, to be used to create the visible hairline, for example. FIG. 33shows creation of the visible hairline, under an embodiment. The visiblehairline is determined and developed with a manual FUT technique. Thevisible hairline and the mass transplant of the vertex may be performedconcurrently or as separate stages. If the visible hairline and masstransplant are performed concurrently, the recipient site is developedstarting with the visible hairline.

Transplantation of harvested hair plugs comprises preparing therecipient site is prepared by resecting non-hair bearing skin plugs in atopographically identical pattern as the pattern of the harvestedoccipital scalp donor site. FIG. 34 shows preparation of the donor siteusing the patterned perforated plate and spring-loaded pixilation deviceto create identical skin defects at the recipient site, under anembodiment. The recipient site of an embodiment is prepared for the masstransplant of the hair plugs using the same perforated plate andspring-loaded pixilation device that was used at the donor site. Scalpdefects are created at the recipient site. These scalp defects have thesame geometry as the harvested plugs on the adherent membrane.

The adherent membrane carrying the harvested hair plugs is applied overthe same pattern of scalp defects at recipient site. Row-by-row eachfollicle-bearing or hair-bearing skin plug is inserted into its mirrorimage recipient defect. FIG. 35 shows transplantation of harvested plugsby inserting harvested plugs into a corresponding skin defect created atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

Clinical endpoints vary from patient to patient, but it is predictedthat a higher percentage of hair plugs will “take” as a result ofimproved neovascularization. FIG. 36 shows a clinical end point usingthe pixel dermatome instrumentation and procedure, under an embodiment.The combination of better “takes”, shorter procedure times, and a morenatural-looking result, enable the pixel dermatome instrumentation andprocedure of an embodiment to overcome the deficiencies in conventionalhair transplant approaches.

Embodiments of pixelated skin grafting for skin defects and pixelatedskin resection for skin laxity are described in detail herein. Theseembodiments remove a field of skin pixels in an area of lax skin whereskin tightening is desired. The skin defects created by this procedure(e.g., in a range of approximately 1.5-3 mm-diameter) are small enoughto heal per primam without visible scarring; the wound closure of themultiple skin defects is performed directionally to produce a desiredcontouring effect. Live animal testing of the pixel resection procedurehas produced excellent results.

The pixel procedure of an embodiment is performed in an office settingunder a local anesthetic but is not so limited. The surgeon uses theinstrumentation of an embodiment to rapidly resect an array of skinpixels (e.g., circular, elliptical, square, etc.). Relatively littlepain is associated with the procedure. The intradermal skin defectsgenerated during the procedure are closed with the application of anadherent Flexan (3M) sheet, but embodiments are not so limited.Functioning as a large butterfly bandage, the Flexan sheet is pulled ina direction that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing toassist aesthetic contouring. During recovery, the patient wears asupport garment over the treatment area for a period of time (e.g., 5days, etc.). After initial healing, the multiplicity of small linearscars within the treatment area is not visibly apparent. Additional skintightening will occur subsequently over several months from the delayedwound healing response. Consequently, the pixel procedure is a minimallyinvasive alternative for skin tightening in areas where the extensivescarring of traditional aesthetic plastic surgery is to be avoided.

The pixel procedure evokes cellular and extracellular responses that areobligatory to the clinical outcomes achieved. A physical reduction ofthe skin surface area occurs due to the fractional resection of skin,which physically removes a portion of skin directly in the area oflaxity. In addition, a subsequent tightening of the skin is realizedfrom the delayed wound healing response. Each pixilated resectioninitiates an obligate wound healing sequence. The healing responseeffected in an embodiment comprises three phases, as previouslydescribed in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells releases histamine into the “wound”.Histamine release evokes dilatation of the capillary bed and increasesvessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

Within days of “wounding”, the second phase of healing, fibroplasia,commences. During fibroplasia, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia has two key features: thedeposition of neocollagen and the myofibroblastic contraction of thewound. Histologically, the deposition of neocollagen is identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the skin significantlyincreases. Myofibroblastic contraction is a dynamic physical processthat results in two-dimensional tightening of the skin surface. Thisprocess is due to the active cellular contraction of myofibroblasts andthe deposition of contractile proteins within the extracellular matrix.Overall, the effect of fibroplasia will be dermal contraction and thedeposition of a static supporting scaffolding of neocollagen with atightened framework. The clinical effect is realized as a delayedtightening of skin with smoothing of skin texture over some number ofmonths. The clinical endpoint is a more youthful appearing skin envelopeof the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During maturation, there is a strengthening and remodelingof the treatment area due to increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within 6 to 12months after “wounding” and may extend for at least 1-2 years. Smallpixilated resections of skin should preserve the normal dermalarchitecture during maturation, but without the creation of a visuallyevident scar that typically occurs with a larger surgical resection ofskin. Lastly, there is a related stimulation and rejuvenation of theepidermis from the release of epidermal growth hormone.

FIGS. 37-42 show images resulting from a pixel procedure conducted on alive animal, under an embodiment. Embodiments described herein were usedin this proof-of-concept study in an animal model that verified thepixel procedure produces aesthetic skin tightening without visiblescarring. The study used a live porcine model, anesthetized for theprocedure. FIG. 37 is an image of the skin tattooed at the corners andmidpoints of the area to be resected, under an embodiment. The fieldmargins of resection were demarcated with a tattoo for post-operativeassessment, but embodiments are not so limited. The procedure wasperformed using a perforated plate (e.g., 10×10 pixel array) todesignate the area for fractional resection. The fractional resectionwas performed using biopsy punches (e.g., 1.5 mm diameter). FIG. 38 isan image of the post-operative skin resection field, under anembodiment. Following the pixel resection, the pixelated resectiondefects were closed (horizontally) with Flexan membrane.

Eleven days following the procedure, all resections had healed perprimam in the area designated by the tattoo, and photographic anddimensional measurements were made. FIG. 39 is an image at 11 daysfollowing the procedure showing resections healed per primam, withmeasured margins, under an embodiment. Photographic and dimensionalmeasurements were subsequently made 29 days following the procedure.FIG. 40 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured margins, under an embodiment. FIG.41 is an image at 29 days following the procedure showing resectionshealed per primam and maturation of the resection field continuing perprimam, with measured lateral dimensions, under an embodiment.Photographic and dimensional measurements were repeated 90 dayspost-operative, and the test area skin was completely smooth to touch.FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primam,with measured lateral dimensions, under an embodiment.

Fractional resection as described herein is performed intradermally orthrough the entire thickness of the dermis. The ability to incise skinwith a scalpet (e.g., round, square, elliptical, etc.) is enhanced withthe addition of additional force(s). The additional force includes forceapplied to the scalpet or scalpet array, for example, where the forcecomprises one or more of rotational force, kinetic impact force, andvibrational force, all of which are described in detail herein for skinfractional resection.

The scalpet device of an embodiment generally includes a scalpetassembly and a housing. The scalpet assembly includes a scalpet array,which comprises a number of scalpets, and force or drive components. Thescalpet assembly includes one or more alignment plates configured toretain and position the scalpets precisely according to theconfiguration of the scalpet array, and to transmit force (e.g., z-axis)from the operator to the subject tissue targeted for resection. Thescalpet assembly includes spacers configured to retain alignment platesat a fixed distance apart and coaxial with the scalpet array, but is notso limited.

A shell is configured to retain the spacers and the alignment plates,and includes attachment point(s) for the housing and drive shaft. Thealignment plates and/or the spacers are attached or connected (e.g.,snapped, welded (e.g., ultrasonic, laser, etc.), heat-staked, etc.) intoposition in the shell, thereby providing a rigid assembly anddiscourages tampering or re-purposing of the scalpet array.Additionally, the shell protects the drive mechanism or gearing andscalpets from contamination during use and allows lubrication (ifrequired) to be applied to the gearing to reduce the torque requirementand increase the life of the gears.

As an example of the application of force using the embodiments herein,the ability to incise skin with a circular scalpet is enhanced with theaddition of a rotational torque. The downward axial force used to incisethe skin is significantly reduced when applied in combination with arotational force. This enhanced capability is similar to a surgeonincising skin with a standard scalpel where the surgeon uses acombination of movement across the skin (kinetic energy) with thesimultaneous application of compression (axial force) to moreeffectively cut the skin surface.

For piercing the skin, the amount of surface compression required issignificantly reduced if a vertical kinetic force is employedsimultaneously. For example, a dart throwing technique for injectionshas previously been used by healthcare providers for piercing skin. An“impactor” action imparted on skin by a circular scalpet of anembodiment enhances this modality's cutting capability by simultaneouslyemploying axial compressive and axial kinetic forces. The axialcompressive force used to incise the skin surface is significantlyreduced if applied in combination with kinetic force.

Conventional biopsy punches are intended for a single use application inthe removal of tissue, which is generally achieved by pushing the punchdirectly into the tissue along its central axis. Similarly, thefractional resection of an embodiment uses scalpets comprising acircular configuration. While the scalpets of an embodiment can be usedin a stand-alone configuration, alternative embodiments include scalpetarrays in which scalpets are bundled together in arrays of various sizesconfigured to remove sections of skin, but are not so limited. The forceused to pierce the skin using the fractional resection scalpet is afunction of the number of scalpets in the array, so that as the arraysize increases the force used to pierce the skin increases.

The ability to incise skin with a circular scalpet is significantlyenhanced with a reduction in the force needed to pierce the skinintroduced through the addition of a rotational motion around itscentral axis and/or an impact force along its central axis. FIG. 43 is ascalpet showing the applied rotational and/or impact forces, under anembodiment. This enhanced rotational configuration has an affect similarto a surgeon incising skin with a standard scalpel where the surgeonuses a combination of movement across the skin (kinetic energy) with thesimultaneous application of compression (axial force) to moreeffectively cut the skin surface. The impact force is similar to the useof a staple gun or by quickly moving a hypodermic needle prior toimpacting the skin.

A consideration in the configuration of the scalpet rotation is theamount of torque used to drive multiple scalpets at a preferred speed,because the physical size and power of the system used to drive thescalpet array increases as the required torque increases. To reduce theincisional force required in a scalpet array, rows or columns orsegments of the array may be individually driven or sequentially drivenduring an array application. Approaches for rotating the scalpetsinclude but are not limited to geared, helical, slotted, inner helical,pin driven, and frictional (elastomeric).

The scalpet array configured for fractional resection using combinedrotation and axial incision uses one or more device configurations forrotation. For example, the scalpet array of the device is configured torotate using one or more of geared, external helical, inner helical,slotted, and pin drive rotating or oscillating mechanisms, but is not solimited. Each of the rotation mechanisms used in various embodiments isdescribed in detail herein.

FIG. 44 shows a geared scalpet and an array including geared scalpets,under an embodiment. FIG. 45 is a bottom perspective view of a resectiondevice including the scalpet assembly with geared scalpet array, underan embodiment. The device comprises a housing (depicted as transparentfor clarity of details) configured to include the geared scalpet arrayfor the application of rotational torque for scalpet rotation. FIG. 46is a bottom perspective view of the scalpet assembly with geared scalpetarray (housing not shown), under an embodiment. FIG. 47 is a detailedview of the geared scalpet array, under an embodiment.

The geared scalpet array includes a number of scalpets as appropriate toa resection procedure in which the array is used, and a gear is coupledor connected to each scalpet. For example, the gear is fitted over oraround a scalpet, but the embodiment is not so limited. The gearedscalpets are configured as a unit or array so that each scalpet rotatesin unison with adjacent scalpets. For example, once fit, the gearedscalpets are installed together in alignment plates so that each scalpetengages and rotates in unison with its adjacent four scalpets and isthereby retained in precise alignment. The geared scalpet array isdriven by at least one rotating external shaft carrying a gear at thedistal end, but is not so limited. The rotational shaft(s) is configuredto provide or transmit the axial force, which compresses the scalpets ofthe array into the skin during incision. Alternatively, axial force maybe applied to the plates retaining the scalpets.

In an alternative embodiment, a frictional drive is used to drive orrotate the scalpets of the arrays. FIG. 48 shows an array includingscalpets in a frictional drive configuration, under an embodiment. Thefrictional drive configuration includes an elastomeric ring around eachscalpet, similar to gear placement in the geared embodiment, andfrictional forces between the rings of adjacent scalpets in compressionresults in rotation of the scalpets similar to the geared array.

The resection devices comprise helical scalpet arrays, including but notlimited to external and internal helical scalpet arrays. FIG. 49 shows ahelical scalpet (external) and an array including helical scalpets(external), under an embodiment. FIG. 50 shows side perspective views ofa scalpet assembly including a helical scalpet array (left), and theresection device including the scalpet assembly with helical scalpetarray (right) (housing shown), under an embodiment. FIG. 51 is a sideview of a resection device including the scalpet assembly with helicalscalpet array assembly (housing depicted as transparent for clarity ofdetails), under an embodiment. FIG. 52 is a bottom perspective view of aresection device including the scalpet assembly with helical scalpetarray assembly (housing depicted as transparent for clarity of details),under an embodiment. FIG. 53 is a top perspective view of a resectiondevice including the scalpet assembly with helical scalpet arrayassembly (housing depicted as transparent for clarity of details), underan embodiment.

The helical scalpet configuration comprises a sleeve configured to fitover an end region of the scalpet, and an external region of the sleeveincludes one or more helical threads. Once each scalpet is fitted with asleeve, the sleeved scalpets are configured as a unit or array so thateach scalpet rotates in unison with the adjacent scalpets.Alternatively, the helical thread is formed on or as a component of eachscalpet.

The helical scalpet array is configured to be driven by a push platethat oscillates up and down along a region of the central axis of thescalpet array. FIG. 54 is a push plate of the helical scalpet array,under an embodiment. The push plate includes a number of alignment holescorresponding to a number of scalpets in the array. Each alignment holeincludes a notch configured to mate with the helical (external) threadon the scalpet sleeve. When the push plate is driven it causes rotationof each scalpet in the array. FIG. 55 shows the helical scalpet arraywith the push plate, under an embodiment.

The resection devices further comprise internal helical scalpet arrays.The device comprises a housing configured to include the helical scalpetarray assembly for the application of rotational torque for scalpetrotation. FIG. 56 shows an inner helical scalpet and an array includinginner helical scalpets, under an embodiment. The inner helical scalpetincludes a twisted square rod (e.g., solid, hollow, etc.) or insert thatis fitted into an open end of the scalpet. Alternatively, the scalpet isconfigured to include a helical region. The twisted insert is held inplace by bonding (e.g., crimping, bonding, brazing, welding, gluing,etc.) a portion of the scalpet around the insert. Alternative, theinsert is held in place with an adhesive bond. Inner helical scalpetsare then configured as a unit or array so that each scalpet isconfigured to rotate in unison with the adjacent scalpets. The helicalscalpet array is configured to be driven by a drive plate that moves oroscillates up and down along the helical region of each scalpet of thescalpet array. The drive plate includes a number of square alignmentholes corresponding to a number of scalpets in the array. When the driveplate is driven up and down it causes rotation of each scalpet in thearray. FIG. 57 shows the helical scalpet array with the drive plate,under an embodiment.

FIG. 58 shows a slotted scalpet and an array including slotted scalpets,under an embodiment. The slotted scalpet configuration comprises asleeve configured to fit over an end region of the scalpet, and thesleeve includes one or more spiral slots. Alternatively, each scalpetincludes the spiral slot(s) without use of the sleeve. The sleevedscalpets are configured as a unit or array so that the top region of theslots of each scalpet are aligned adjacent one another. An externaldrive rod is aligned and fitted horizontally along the top of the slots.When the drive rod is driven downward, the result is a rotation of thescalpet array. FIG. 59 shows a portion of a slotted scalpet array (e.g.,four (4) scalpets) with the drive rod, under an embodiment. FIG. 60shows an example slotted scalpet array (e.g., 25 scalpets) with thedrive rod, under an embodiment.

FIG. 61 shows an oscillating pin drive assembly with a scalpet, under anembodiment. The assembly includes a lower plate and a middle platecoupled or connected to the scalpet(s) and configured to retain thescalpet(s). A top plate, or drive plate, is positioned in an area abovethe scalpet and the middle plate, and includes a drive slot or slot. Apin is coupled or connected to a top portion of the scalpet, and a topregion of the pin extends beyond a top of the scalpet. The slot isconfigured to receive and loosely retain the pin. The slot is positionedrelative to the pin such that rotation or oscillation of the top platecauses the scalpet to rotate or oscillate via tracking of the pin in theslot.

One or more components of the scalpet device include an adjustmentconfigured to control the amount (e.g., depth) of scalpet exposureduring deployment of the scalpet array at the target site. For example,the adjustment of an embodiment is configured to collectively control alength of deployment of the scalpets of a scalpet array. The adjustmentof an alternative embodiment is configured to collectively control alength of deployment of a portion or set of scalpets of a scalpet array.In another example embodiment, the adjustment is configured toseparately control a length of deployment of each individual scalpet ofa set of scalpets or scalpet array. The scalpet depth control includesnumerous mechanisms configured for adjustable control of scalpet depth.

The depth control of an embodiment includes an adjustable collar orsleeve on each scalpet. The collar, which is configured for movement(e.g., slideable, etc.) along a length of the scalpet, is configured toprevent penetration of the scalpet into target tissue beyond a depthcontrolled by a position of the collar. The position of the collar isadjusted by a user of the scalpet device prior to use in a procedure,where the adjustment includes one or more of a manual adjustment,automatic adjustment, electronic adjustment, pneumatic adjustment, andadjustment under software control, for example.

The depth control of an alternative embodiment includes an adjustableplate configured for movement along a length of scalpets of the scalpetarray. The plate is configured to prevent penetration of the scalpets ofthe scalpet array into target tissue beyond a depth controlled by aposition of the plate. In this manner, the scalpet array is deployedinto the target tissue to a depth equivalent to a length of the scalpetsprotruding beyond the plate. The position of the plate is adjusted by auser of the scalpet device prior to use in a procedure, where theadjustment includes one or more of a manual adjustment, automaticadjustment, electronic adjustment, pneumatic adjustment, and adjustmentunder software control, for example.

As an example of depth control adjustment using a plate, the variablelength scalpet exposure is controlled through adjustments of the scalpetguide plates of the scalpet assembly, but is not so limited. FIG. 62shows variable scalpet exposure control with the scalpet guide plates,under an embodiment. Alternative embodiments control scalpet exposurefrom within the scalpet array handpiece, and/or under one or more ofsoftware, hardware, and mechanical control.

Embodiments include a mechanical scalpet array in which axial force androtational force are applied manually by the compressive force from thedevice operator. FIG. 63 shows a scalpet assembly including a scalpetarray (e.g., helical) configured to be manually driven by an operator,under an embodiment.

Embodiments include and/or are coupled or connected to a source ofrotation configured to provide optimal rotation (e.g., RPM) androtational torque to incise skin in combination with axial force.Optimal rotation of the scalpets is configured according to the bestbalance between rotational velocity and increased cutting efficiencyversus increased frictional losses. Optimal rotation for each scalpetarray configuration is based on one or more of array size (number ofscalpets), scalpet cutting surface geometry, material selection ofscalpets and alignment plates, gear materials and the use oflubrication, and mechanical properties of the skin, to name a few.

Regarding forces to be considered in configuration of the scalpets andscalpet arrays described herein, FIG. 64 shows forces exerted on ascalpet via application to the skin. The parameters considered indetermining applicable forces under an embodiment include the following:

-   -   Average Scalpet Radius: r    -   Scalpet Rotation Rate: ω    -   Scalpet Axial Force: F_(n) (scalpet applied normal to skin)    -   Skin Friction Coefficient: μ    -   Friction Force: F_(f)    -   Scalpet Torque: τ    -   Motor Power: P_(hp).

Upon initial application, the torque used to rotate the scalpet is afunction of the axial force (applied normally to the surface of theskin) and the coefficient of friction between the scalpet and the skin.This friction force initially acts on the cutting surface of thescalpet. At initial application of scalpet to skin:F _(f) =μ·F _(n)τ=F _(f) ·rP _(hp)=τ·ω/63025

The initial force for the scalpet to penetrate the skin, is a functionof the scalpet sharpness, the axial force, the tensile strength of theskin, the coefficient of friction between the skin and the scalpet.Following penetration of the scalpet into the skin, the friction forceincreases as there are additional friction forces acting on the sidewalls of the scalpet.

Resection devices of embodiments include kinetic impaction incisiondevices and methods for non-rotational piercing of the skin. Approachesfor direct compression of the scalpet into the skin include, but are notlimited to, axial force compression, single axial force compression pluskinetic impact force, and moving of the scalpet at a high velocity toimpact and pierce the skin. FIG. 65 depicts steady axial forcecompression using a scalpet, under an embodiment. Steady axial forcecompression places the scalpet in direct contact with the skin. Once inplace, a continuous and steady axial force is applied to the scalpetuntil it pierces the skin and proceeds through the dermis to thesubcutaneous fat layer.

FIG. 66 depicts steady single axial force compression plus kineticimpact force using a scalpet, under an embodiment. Steady single axialforce compression plus kinetic impact force places the scalpet in directcontact with the skin. An axial force is applied to maintain contact.The distal end of the scalpet is then struck by another object,imparting additional kinetic energy along the central axis. These forcescause the scalpet to pierce the skin and proceed through the dermis tothe subcutaneous fat layer.

FIG. 67 depicts moving of the scalpet at a velocity to impact and piercethe skin, under an embodiment. The scalpet is positioned a shortdistance away from a target area of the skin. A kinetic force is appliedto the scalpet to achieve a desired velocity for piercing the skin. Thekinetic force causes the scalpet to pierce the skin and proceed throughthe dermis to the subcutaneous fat layer.

Scalpets of an embodiment include numerous cutting surface or bladegeometries as appropriate to an incision method of a procedure involvingthe scalpet. The scalpet blade geometries include, for example, straightedge (e.g., cylindrical), beveled, multiple-needle tip (e.g., sawtooth,etc.), and sinusoidal, but are not so limited. As but one example, FIG.68 depicts a multi-needle tip, under an embodiment.

The scalpets include one or more types of square scalpets, for example.The square scalpets include but are not limited to, square scalpetswithout multiple sharpened points, and square scalpets with multiplesharpened points or teeth. FIG. 69 shows a square scalpet without teeth(left), and a square scalpet with multiple teeth (right), under anembodiment.

The fractional resection devices of an embodiment involve the use of asquare scalpet assembled onto a scalpet array that has multiplesharpened points to facilitate skin incising through directnon-rotational kinetic impacting. The square geometry of the harvestedskin plug provides side-to-side and point-to-point approximation of theassembled skin plugs onto the adherent membrane. Closer approximation ofthe skin plugs provides a more uniform appearance of the skin graft atthe recipient site. In addition, each harvested component skin plug willhave additional surface area (e.g., 20-25%).

Further, the scalpets include one or more types of elliptical or roundscalpets. The round scalpets include but are not limited to, roundscalpets with oblique tips, round scalpets without multiple sharpenedpoints or teeth, and round scalpets with multiple sharpened points orteeth. FIG. 70 shows multiple side, front (or back), and sideperspective views of a round scalpet with an oblique tip, under anembodiment. FIG. 71 shows a round scalpet with a serrated edge, under anembodiment.

The resection device of an embodiment is configured to include extrusionpins corresponding to the scalpets. FIG. 72 shows a side view of theresection device including the scalpet assembly with scalpet array andextrusion pins (housing depicted as transparent for clarity of details),under an embodiment. FIG. 73 shows a top perspective cutaway view of theresection device including the scalpet assembly with scalpet array andextrusion pins (housing depicted as transparent for clarity of details),under an embodiment. FIG. 74 shows side and top perspective views of thescalpet assembly including the scalpet array and extrusion pins, underan embodiment.

The extrusion pins of an embodiment are configured to clear retainedskin plugs, for example. The extrusion pins of an alternative embodimentare configured to inject into fractional defects at the recipient site.The extrusion pins of another alternative embodiment are configured toinject skin plugs into pixel canisters of a docking station forfractional skin grafting.

Embodiments herein include the use of a vibration component or system tofacilitate skin incising with rotation torque/axial force and to usevibration to facilitate skin incising with direct impaction withoutrotation. FIG. 75 is a side view of a resection device including thescalpet assembly with scalpet array assembly coupled to a vibrationsource, under an embodiment.

Embodiments herein include an electro-mechanical scalpet arraygenerator. FIG. 76 shows a scalpet array driven by an electromechanicalsource or scalpet array generator, under an embodiment. The function ofthe generator is powered but is not electronically controlled, butembodiments are not so limited. The platform of an embodiment includescontrol software.

Embodiments include and/or are coupled or connected to a supplementaryenergy or force configured to reduce the axial force used to incise skin(or another tissue surface such as mucosa) by a scalpet in a scalpetarray. Supplemental energies and forces include one or more ofrotational torque, rotational kinetic energy of rotation (RPM),vibration, ultrasound, and electromagnetic energy (e.g., RF, etc.), butare not so limited.

Embodiments herein include a scalpet array generator comprising and/orcoupled to an electromagnetic radiation source. The electromagneticradiation source includes, for example, one or more of a Radio Frequency(RF) source, a laser source, and an ultrasound source. Theelectromagnetic radiation is provided to assist cutting with thescalpets.

Embodiments include a scalpet mechanism configured as a “sewing machine”scalpet or scalpet array in which the scalpets are repeatedly retractedand deployed under one or more of manual, electromechanical, andelectronic control. This embodiment includes a moving scalpet or scalpetarray to resect a site row-by-row. The resection can, for example takethe form of a stamping approach where the scalpet or scalpet arraymoves, or the array could be rolled over the surface to be treated andthe scalpet array resection at given distances traveled to achieve thedesired resection density.

The fractional resection devices described herein are configured forfractional resection and grafting in which the harvesting offractionally incised skin plugs is performed with a vacuum that depositsthe plugs within the lumen of each scalpet shaft. The skin plugs arethen inserted into a separate docking station described herein by aproximal pin array that extrudes the skin plug from within the shaft ofthe scalpet.

FIG. 77 is a diagram of the resection device including a vacuum system,under an embodiment. The vacuum system comprises vacuum tubing and avacuum port on/in the device housing, configured to generate a vacuumwithin the housing by drawing air out of the housing. The vacuum of anembodiment is configured to provide vacuum stenting/fixturing of theskin for scalpet incising, thereby providing improved depth control andcutting efficiency.

The vacuum of an alternative embodiment is configured for vacuumevacuation or harvesting of skin plugs and/or hair plugs through one ormore of a scalpet lumen and an array manifold housing. FIG. 78 shows avacuum manifold applied to a target skin surface to evacuate/harvestexcised skin/hair plugs, under an embodiment. The vacuum manifold, whichis configured for direct application onto a skin surface, is coupled orconnected to a vacuum source. FIG. 79 shows a vacuum manifold with anintegrated wire mesh applied to a target skin surface toevacuate/harvest excised skin/hair plugs, under an embodiment.

Additionally, an external vacuum manifold is used with asuction-assisted lipectomy machine to percutaneously evacuatesuperficial sub-dermal fat through fractionally resection skin defectsin a fractionally created field for the treatment of cellulite. FIG. 80shows a vacuum manifold with an integrated wire mesh configured tovacuum subdermal fat, under an embodiment.

The external vacuum manifold can also be configured to include and bedeployed with an incorporated docking station (described herein) toharvest skin plugs for grafting. The docking station can be one or moreof static, expandable, and/or collapsible.

The fractional resection devices described herein comprise a separatedocking station configured as a platform to assemble the fractionallyharvested skin plugs into a more uniform sheet of skin for skingrafting. The docking station includes a perforated grid matrixcomprising the same pattern and density of perforations as the scalpetson the scalpet array. A holding canister positioned subjacent to eachperforation is configured to retain and maintain alignment of theharvested skin plug. In an embodiment, the epidermal surface is upwardat the level of the perforation. In an alternative embodiment, thedocking station is partially collapsible to bring docked skin plugs intocloser approximation prior to capture onto an adherent membrane. Thecaptured fractional skin graft on the adherent membrane is then defattedwith either an incorporated or non-incorporated transection blade. Inanother alternative embodiment, the adherent membrane itself has anelastic recoil property that brings or positions the captured skin plugsinto closed alignment. Regardless of embodiment, the contractedfractional skin graft/adherent membrane composite is then directlyapplied to the recipient site defect.

Embodiments include a collapsible docking station or tray configured toaccept and maintain orientation of harvested skin and/or hair plugs oncethey have been removed or ejected from the scalpets via the extrusionpins. FIG. 81 depicts a collapsible docking station and an inserted skinpixel, under an embodiment. The docking station is formed fromelastomeric material but is not so limited. The docking station isconfigured for stretching from a first shape to a second shape thataligns the pixel receptacles with the scalpet array on the handpiece.FIG. 82 is a top view of a docking station (e.g., elastomeric) instretched (left) and un-stretched (right) configuration, under anembodiment, under an embodiment.

The pixels are ejected from the scalpet array into the docking stationuntil it is full, and the docking station is then relaxed to itspre-stretched shape, which has the effect of bringing the pixels incloser proximity to each other. A flexible semi-permeable membrane withadhesive on one side is then stretched and placed over the dockingstation (adhesive side down). Once the pixels are adhered to themembrane, it is lifted away from the docking station. The membrane thenreturns to its normal un-stretched state, which also has the effect ofpulling the pixels closer to each other. The membrane is then placedover the recipient defect.

Resection devices described herein include delivery of therapeuticagents through resectioned defects generated with the resection devicesdescribed herein. As such, the resection sites are configured for use astopically applied infusion sites for delivery or application oftherapeutic agents for the reduction of fat cells (lipolysis) during orafter a resectioning procedure.

Embodiments herein are configured for hair transplantation that includesvacuum harvesting of hair plugs into the scalpet at the donor site, anddirect mass injection (without a separate collection reservoir) ofharvested hair plugs into the fractionally resected defects of therecipient site. Under this embodiment, the donor scalpet array deployedat the occipital scalp comprises scalpets having a relatively largerdiameter than the constituent scalpets of the scalpet array deployed togenerate defects at the recipient site. Following harvesting of hairplugs at the donor site, the defects generated at the recipient site areplugged using the harvested hair plugs transferred in the scalpet array.

Due to the elastic retraction of the incised dermis, the elasticallyretracted diameter of the hair plug harvested at the occipital scalpwill be similar to the elastically retracted diameter of thefractionally resected defect of the recipient site at thefrontal-parietal-occipital scalp. In an embodiment, hair plugs harvestedwithin the donor scalpet array are extruded directly with proximal pinsin the lumen of the scalpet into a same pattern of fractionally defectscreated by the recipient site scalpet array. The scalpets (containingthe donor hair plugs) of the scalpet array deployed at the donor siteare aligned (e.g., visually) with the same pattern of fractionallyresected field of defects at the recipient scalp site. Upon alignment, aproximal pin within the shaft of each scalpet is advanced down the shaftof the scalpet to extrude the hair plug into the fractionally resecteddefect of the recipient site, thereby effecting a simultaneoustransplantation of multiple hair plugs to the recipient site. This masstransplantation of hair plugs into a fractionally resected recipientsite (e.g., of a balding scalp) is more likely to maintain the hairshaft alignment with other mass transplanted hair plugs of thatrecipient scalp site. Directed closure of the donor site field isperformed in the most clinically effective vector, but is not solimited.

The fractional resection devices described herein are configured fortattoo removal. Many patients later in life desire removal of pigmentedtattoos for a variety of reasons. Generally, removal of a tattooinvolves the removal of the impregnated pigment within the dermis.Conventional tattoo removal approaches have been described from thermalablation of the pigment to direct surgical excision. Thermal ablation bylasers frequently results in depigmentation or area surface scarring.Surgical excision of a tattoo requires the requisite linear scarring ofa surgical procedure. For many patients, the tradeoff between tattooremoval and the sequela of the procedure can be marginal.

The use of fractional resection to remove a tattoo allows for fractionalremoval of a significant proportion of the dermal pigment with minimalvisible scarring. The fractional resection extends beyond the border ofthe tattoo to blend the resection into the non-resected and non-tattooedskin. Most apparently, de-delineation of the pattern of the tattoo willoccur even if all residual pigment is not or cannot be removed. In anembodiment, initial fractional resections are performed with a scalpetarray, and any subsequent fractional resections are performed bysingular scalpet resections for residual dermal pigment. As with otherapplications described herein, directed closure is performed in the mostclinically effective vector.

The fractional resection devices described herein are configured fortreatment of cellulite. This aesthetic deformity has resisted effectivetreatment for several decades as the pathologic mechanism of action ismultifactorial. Cellulite is a combination of age or weight loss skinlaxity with growth and accentuation of the superficial fat loculations.The unsightly cobblestone appearance of the skin is commonly seen in thebuttocks and lateral thighs. Effective treatment should address eachcontributing factor of the deformity.

The fractional resection devices described herein are configured forfractional resection of the skin in order to tighten the affected skinand to simultaneously reduce the prominent fat loculations that arecontributing to the cobblestone surface morphology. Through the samefractionally resected defects created for skin tightening, topicallyapplied vacuum is used to suction the superficial fat loculationspercutaneously. In an embodiment, a clear manifold suction cannula isapplied directly to the fractionally resected skin surface. Theappropriate vacuum pressure used with the suction-assisted lipectomy(SAL) unit is determined by visually gauging that the appropriate amountof sub-dermal fat being suction resected. The appropriate time period ofmanifold application is also a monitored factor in the procedure. Whencombined with fractional skin tightening, only a relatively small amountof fat is suction resected to produce a smoother surface morphology. Aswith other applications described herein, the fractionally resectedfield will be closed with directed closure.

The fractional resection devices described herein are configured forrevision of abdominal striae and scarring. Visually apparent scarring isa deformity that requires clear delineation of the scar from theadjacent normal skin. Delineation of the scar is produced by changes intexture, in pigment and in contour. To make a scar less visiblyapparent, these three components of scarring must be addressed for ascar revision to significantly reduce the visual impact. Severe scarscalled contractures across a joint may also limit the range of motion.For the most part, scar revisions are performed surgically where thescar is elliptically excised and carefully closed by careful coaptationof excised margins of the non-scarred skin. However, any surgicalrevision reintroduces and replaces the pre-existing scar with anincumbent surgical scar that may be also be delineated or only partiallyde-delineated by a Z or W plasty.

Scarring is bifurcated diagnostically into hypertrophic and hypotrophictypes. The hypertrophic scar typically has a raised contour, irregulartexture and is more deeply pigmented. In contrast, the hypotrophic scarhas a depressed contour below the level of the adjacent normal unscarredskin. In addition, the color is paler (depigmented) and the texture issmoother than the normal adjacent skin. Histologically, hypertrophicscars posses an abundance of disorganized dermal scar collagen withhyperactive melanocytes. Hypotrophic scars have a paucity of dermalcollagen with little or no melanocytic activity.

The fractional resection devices described herein are configured forfractional scar revision of a scar that does not reintroduce additionalsurgical scarring but instead significantly de-delineates the visualimpact of the deformity. Instead of a linear surgically induced scar,the fractional resection of the scar results in a net reduction of thepigmentary, textural and contour components. A fractional revision isperformed along the linear dimension of the scar and also extends beyondthe boundary of the scar into the normal skin. The fractional revisionof a scar involves the direct fractional excision of scar tissue withmicro-interlacing of the normal non-scarred skin with the residual scar.Essentially, a micro W-plasty is performed along the entire extent ofthe scar. As with other applications, the fractionally resected field isclosed with directed closure. An example of the use of fractionalrevision includes revising a hypotrophic post-partum abdominal stria.The micro-interlacing of the depressed scar epithelium and dermis of thestria with the adjacent normal skin significantly reduces the depressed,linear and hypo-pigmented appearance of this deformity.

The fractional resection devices described herein are configured forvaginal repair for postpartum laxity and prolapse. The vaginal deliveryof a full term fetus involves in part the massive stretching of thevaginal introitus and vaginal canal. During delivery, elongation of thelongitudinal aspect of the vaginal canal occurs along withcross-sectional dilatation of the labia, vaginal introitus and vaginalvault. For many patients, the birth trauma results in a permanentstretching of the vaginal canal along the longitudinal andcross-sectional aspects. Vaginal repair for prolapse is typicallyperformed as an anterior-posterior resection of vaginal mucosa withinsertion of prosthetic mesh. For patients with severe prolapse, thisprocedure is required as addition support of the anterior and posteriorvaginal wall is needed. However, many patients with post-partum vaginallaxity may be candidates for a less invasive procedure.

The fractional resection devices described herein are configured forfractional resection of the vaginal mucosa circumferentially to narrowthe dilated vaginal canal at the labia and the introitus. The patternfor fractional resection can also be performed in a longitudinaldimension when the vaginal canal is elongated. Directed closure of thefractional field can be assisted with a vacuum tampon that will act asstent to shaped the fractionally resected vaginal canal into apre-partum configuration.

The fractional resection devices described herein are configured fortreatment of snoring and sleep apnea. There are few health implicationsof snoring but the disruptive auditory effect upon the relationship ofsleeping partners can be severe. For the most part, snoring is due tothe dysphonic vibration of intraoral and pharyngeal soft tissuestructures within the oral, pharyngeal and nasal cavities duringinspiration and expiration. More specifically, the vibration of the softpalate, nasal turbinates, lateral pharyngeal walls and base of thetongue are the key anatomic structures causing snoring. Many surgicalprocedures and medical devices have had limited success in amelioratingthe condition. Surgical reductions of the soft palate are frequentlycomplicated with a prolonged and painful recovery due to bacterialcontamination of the incision site.

The fractional resection devices described herein are configured forfractional resection of the oropharyngeal mucosa in order to reduce theage related mucosal redundancy (and laxity) of intraoral and pharyngealsoft tissue structures and not be complicated with prolonged bacterialcontamination of the fractional resection sites. The reduction in sizeand laxity of these structures reduces vibration caused by the passageof air. A perforated (to spray a topical local anesthetic onto thefractional resection field) intraoral dental retainer (that is securedto the teeth and wraps around the posterior aspect of the soft palate)is used to provide directed closure in the anterior-posterior dimensionof the soft palate. A more severe condition called sleep apnea does haveserious health implications due to the hypoxia caused by upper airwayobstruction during sleep. Although CPAP has become a standard for thetreatment of sleep apnea, selective fractional resection of the base ofthe tongue and the lateral pharyngeal walls can significantly reducesleep related upper airway obstruction.

The fractional resection devices described herein are configured forfractional skin culturing/expansion, also referred to herein as“Culturespansion”. The ability to grow skin organotypically would be amajor accomplishment for patients with large skin defects such as burnsand trauma and major congenital skin malformations such port-wine stainsand large ‘bathing trunk’ nevi. Conventional capability is limited toproviding prolonged viability of harvested skin, although some reportshave indicated that wound healing has occurred with organotypic skincultured specimens. It has been reported that enhanced cultured outcomeswill occur with better substrates, cultured media and more effectivefiltration of metabolic byproducts. The use of gene expressionproteinomics for growth hormone and wound healing stimulation is alsopromising. To date however, there is no report that skin has been grownorganotypically.

The fractional harvesting of autologous donor skin for skin graftingunder an embodiment provides an opportunity in the organotypic cultureof skin that did not previously exist. The deposition of a fractionallyharvested skin graft onto a collapsible docking station, as provided bythe embodiments described herein, enables skin plugs to be brought intocontact apposition with each other. The induction of a primary woundhealing process can convert a fractional skin graft into a solid sheetby known or soon to be developed organotypic culture methodology.Further, the use of mechanical skin expansion can also greatly increasethe surface area of the organotypically preserved/grown skin. Invitrosubstrate device iterations include without limitation, an expandabledocking station comprising fractionally harvested skin plugs and aseparate substrate (e.g., curved, flat, etc.) expander that iscontrollable to provide a gradual and continual expansion of the fullthickness organotypically cultured skin. Additionally, the use oforganotypic skin expansion may provide a continual and synergisticwound-healing stimulus for organotypic growth. A gradual and continualexpansion is less likely to delaminate (the basement membrane) theepidermis from the dermis. Additionally, organotypic skin expansionhelps avoid the surgical risk and pain associated in-vivo skinexpansion.

The fractional resection devices described herein enable methods for theorganotypic expansion of skin. The methods comprise an autologousfractional harvest of skin from a donor site of a patient. The use of asquare scalpet array, for example, provides upon transfer side-to-sideand tip-to-tip coaptation of fractionally harvested skin plugs. Themethod comprises transfer of the fractional skin plugs to a collapsibledocking station that maintains orientation and provides apposition ofskin plugs. The docked skin plugs are captured onto a porous adherentmembrane that maintains orientation and apposition. The semi-elasticrecoil property of the adherent membrane provides additional contact andapposition of skin plugs. The method includes transfer of the adherentmembrane/fractional graft composite to a culture bay comprising asubstrate and a culture media that retains viability and promotesorganotypic wound healing and growth. Following healing of skin plugmargins, the entire substrate is placed into a culture bath that has amechanical expander substrate. Organotypic expansion is then initiatedin a gradual and continuous fashion. The expanded full thickness skin isthen autologously grafted to the patient's recipient site defect.

Organotypic skin expansion can be performed on non-fractional skingrafts or more generally, on any other tissue structure as organotypicexpansion. The use of mechanical stimulation to evoke a wound healingresponse for organotypic culture can also be an effective adjunct.

The embodiments described herein are used with and/or as components ofone or more of the devices and methods described in detail herein and inthe Related Applications incorporated herein by reference. Additionally,the embodiments described herein can be used in devices and methodsrelating to fractional resection of skin and fat.

Embodiments include a novel minimally invasive surgical discipline withfar-reaching advantages to conventional plastic surgery procedures.Fractional resection of skin is applied as new stand-alone procedures inanatomical areas that are off limits to conventional plastic surgery dueto the poor tradeoff between the visibility of the incisional scar andamount of enhancement obtained. Fractional resection of skin is alsoapplied as an adjunct to established plastic surgery procedures such asliposuction, and is employed to significantly reduce the length ofincisions required for a particular application. The shortening ofincisions has application in both the aesthetic and reconstructiverealms of plastic surgery. Without limitation, both the procedural andapparatus development of fractional resection are described in detailherein.

Embodiments described herein are configured to remove multiple smallsections of skin without scarring in lieu of the conventional linearresections of skin. The removal of multiple small sections of skinincludes removal of lax excess skin without apparent scarring. As anexample, FIG. 83 depicts removal of lax excess skin without apparentscarring, under an embodiment. The removal of multiple small sections ofskin also includes tightening of skin without apparent scaring, forexample, FIG. 84 depicts tightening of skin without apparent scaring,under an embodiment. The removal of multiple small sections of skinfurther includes fractional skin tightening in which the clinicalendpoint results in three-dimensional contouring of the skin envelop.FIG. 85 depicts three-dimensional contouring of the skin envelop, underan embodiment.

The clinical effectiveness of any surgical manipulation requires athrough understanding of the underlying processes that lead reliably toa clinical endpoint. For fractional skin tightening and contouring, anumber of mechanisms of action are described herein. The principlemechanism of action identified is the conversion of two-dimensionalfractional skin tightening into three-dimensional aesthetic contouring(e.g., see FIG. 3). Contributory to that principle clinical endpoint aresecondary mechanisms of action that serve in concert with each other.The contributory mechanisms of action are described herein according totheir capability to achieve the clinical endpoint, but are not solimited.

The density of fractional resection within an outlined fractional fieldis a primary determinate of two-dimensional skin tightening contributingto three-dimensional contouring. Generally, the density is thepercentage of fractionally resected skin within the fractional field butis not so limited. FIG. 86 depicts variable fractional resectiondensities in a treatment area, under an embodiment. The density offractional resection (“fractional density”) can be varied to providemore selected skin tightening and contouring while providing smoothertransitions into non-fractionally resected areas. Therefore, forexample, transitions into non-fractionally resected areas include areduction in the fractional density but are not so limited.

Another mechanism of action associated with fractional skin resection isthe fractional resection of fat. FIG. 87 depicts fractional resection offat, under an embodiment. Immediately subjacent to the skin are thesub-dermal and subcutaneous fat layers where a variable amount of fat(based on depth and/or amount) can be fractionally resected inanatomical continuity with the resected skin plug. A variable amount offat fractionally resected, and hence an amount of skin tightening andcontouring, is controlled in an embodiment by controlling one or more ofa depth of the resection at the target site and an amount of fatresected. Thus, the density of fractional resection (“fractionaldensity”) can be varied by controlling one or more of fractionaldensity, resection depth, and amount of fact resected in order toprovide more selected skin tightening and contouring while providingsmoother transitions into non-fractionally resected areas. Therefore,for example, transitions into non-fractionally resected areas include areduction in a combination of fractional density, resection depth, andamount of fact resected, but are not so limited.

An additional modality for fractional fat resection is the percutaneousvacuum resection (PVR) of fat directly through the skin fractionaldefects. Numerous clinical applications of fractional fat resection areanticipated in the embodiments herein. The most significant aestheticapplication of fractional fat resection is the reduction of cellulite.The combined in-continuity application of fractional skin and fatresection directly addresses the underlying pathology of this aestheticdeformity. The skin laxity and prominent loculations of fat producingvisible surface cobblestoning of skin morphology are each resolved inconcert with the application of this minimally invasive resectioncapability. FIG. 88 depicts cobblestoning of the skin surface.

Furthermore, another general application includes the ability to alterthree-dimensional contour abnormalities with a combined in-continuityapproach of fractional skin tightening and inward contouring fromfractional fat resection. The pre-operative topographical contourmapping of the fractional field assists in providing a more predictableclinical outcome. Essentially, a topographical mapping oftwo-dimensional fractional skin resection is combined with a variablemarking for fat resection. FIG. 89 depicts topographic mapping for adeeper level of fractional fat resection, under an embodiment. Mappingalso includes the feathering or transition zones into non-resected areaswhere the fractional density is reduced. Depending upon thepre-operative topographical marking of the patient, a variable amount offat is fractionally resected in continuity with fractional skinresection.

Areas to be corrected comprising convex contours undergo deeperfractional fat resections. Concave (or depressed) areas to be correctedare corrected using fractional skin resection. The net result within themapped fractional field is overall smoothing of three-dimensionalcontours with two-dimensional tightening of the skin.

The use of combined fractional resection is most apparent with thereduction in the length required for conventional plastic surgeryincisions and with the elimination of iatrogenic incisional skinredundancies (“Dog Ears”). Standard resection of skin lesions does notrequire the additional scarring of elliptical incisions but issignificantly reduced in the linear dimension required for closure of anexcised lesion (see FIG. 94).

An additional mechanism of action associated with fractional skinresection is the size of the overall outlined pattern of the fractionalresection field. The overall amount of fractionally resected skin alsodepends on the size of the fractionally resected field. The larger thefield, the more skin tightening occurs with a specified density offractional resection. FIG. 90 depicts multiple treatment outlines, underan embodiment.

The mechanism of action of a patterned outline includes the selectivecurvilinear patterning of each particular anatomical area for eachparticular patient. A topographical analysis with a digitally capturedimage of the patient involving a rendered (and re-rendered to anenhanced contour) digital wire mesh program assists in formatting thesize and curvilinear outline for a selected anatomical region andpatient. The pattern of standard aesthetic plastic surgery excisions fora particular anatomic region also assists in the formatting of thefractional resection pattern. FIG. 91 depicts a curvilinear treatmentpattern, under an embodiment. FIG. 92 depicts a digital image of apatient with rendered digital wire mesh program, under an embodiment.

Directed closure of a fractionally resected field of an embodimentprovides the capability of selectively tightening skin to achieveenhanced aesthetic contouring. For most applications, the closure occursat right angles to Langer's lines but may also be done at a differentdirection that achieves maximal aesthetic contour such as closures thatare based on resting skin tension lines. FIG. 93 depicts directedclosure of a fractionally resected field, under an embodiment. Thedirected closure may also follow known vectors of closure used inconventional plastic surgery procedures (e.g., facelift for thefacial/submental component of the facelift is upwards (corresponding toa horizontal directed closure of a fractional field) and the neckcomponent below the cervical mandibular angle is more obliquelyposterior (corresponding to a more vertical directed closure of thefractional field)). Multiple vectors of directed closure may also beused in more complicated topographical regions such as the face andneck.

Embodiments include directed fractional resection of skin, whichenhances the effectiveness of the procedure. This process is performedby pre-stretching the skin at right angles to the preferred direction ofmaximal skin resection. FIG. 94 depicts directed fractional resection ofskin, under an embodiment.

Embodiments include aesthetic contouring resulting from the mechanicalpull (or vector) created from an adjacent fractional field adjacent tothe targeted contour. This effect for a fractional field is based onplastic surgical procedures that are directed a distance from thetargeted contour. Further, variable topographical transitioning ofresection densities within the field and along the pattern outline arerealized, which provide selective contouring and smoother transitioninginto non-resected areas. Additionally, variable topographicaltransitioning of scalpet size resections within a patterned outline (andwith different scalpet sizes within an array) provides selectivetwo-dimensional skin tightening and three-dimensional contouring.

Embodiments described herein evoke a selective wound healing sequencewith promotion of primary healing during the immediate post-operativeperiod and delayed secondary contraction of skin during the collagenproliferative phase. Promotion of accurate coaptation of the skinmargins is inherent to the multiple (fractional) resections of smallsegments of skin i.e., skin margins are more closely aligned prior toclosure than larger linear resections of skin that are common withstandard plastic surgery incisions. Subsequent evoking of woundcontraction is also inherent to a fractionally resected field whereelongation of the pattern of fractional resection provides a directedwound healing response along the longitudinal dimension of thefractionally resected pattern.

Clinical methods of fractional skin resection involve methods ofdirectional closure. Depending upon the anatomical area, the directedclosure of excisional skin defects within a fractional resection fieldis achieved by following Langer's lines, the resting skin lines, and/orin a direction that achieves the maximal of aesthetic contouring. Thedirection in which closure is most easily achieved can also be used as aguide for the most effective vector of directed closure. For manyapplications, the use of Langer's lines is used as a guide to providemaximal aesthetic tightening. Following the original work of Dr. Langer,the fractionally resected defects will elongate in the direction of aLanger line. The directed closure is performed at right angles toLanger's lines in an anatomical region where the skin margins of eachfractional resection defect are in closest approximation.

In continuity fractional procedures that are deployed adjacent or incontinuity with plastic surgery incisions, the most significantcapability provided by the embodiments herein includes the ability toshorten incisions. The need for elliptical excisions of skin tumors isreduced in both the application of this technique and in the length ofthe incision. Thus, the need to excise the lateral extension of a tumorresection is obviated by the fractional resection at that same lateralaspect. FIG. 95 depicts shortening of incisions through continuityfractional procedures, under an embodiment.

As the fractional field under an embodiment heals without visiblescarring, the net result is significant reduction in the length of theexcisional scar. Another application within this category is theshortening of conventional plastic surgery incisions used for breastreduction, Mastopexy and abdominoplasty. The lateral extent of theseincisions can be shortened without the creation of “dog ear” skinredundancies that would otherwise occur with the same length incision.FIG. 96 is an example depiction of “dog ear” skin redundancies in breastreduction and abdominoplasty. For example, extensions of the incisionbeyond the lateral inframmary fold for breast reduction or beyond theIliac crest for abdominoplasty would no longer be required. Fractionalrevisions of post-operative “dog ear” skin redundancies could also beperformed without extension of the existing incision.

Embodiments include combined procedures that provide aestheticenhancement at both the fractional resection harvest site and arecipient site. The most apparent application of this method is the useof fractional harvesting of the cervical beard for hair transplantationin the frontal and parietal scalp. A dual benefit is created by theprocedure in which aesthetic contouring is created along the anteriorneck and with restoration of the hair bearing scalp.

Embodiments include separate fractional procedures in anatomical areasthat are not currently addressed by plastic surgery due to the poortradeoff between the visibility of the surgical incision and the amountof aesthetic enhancement. Several examples exist in this category suchas the supra-patellar knee, the upper arm, the elbow, bra skinredundancy of the back, and the medial and lateral thighs and theinfragluteal folds.

Embodiments include adjunct fractional procedures that are deployed withconventional plastic surgery incisions in a non-contiguous fashion. Thiscategory includes suction-assisted lipectomy in which subcutaneous fatis removed by suction in areas of lipodystrophy such as the lateral hipsand thighs. However, many patients have pre-existing skin laxity that isaggravated by suction lipectomy. The tightening of the skin envelopeover these areas by fractional resection has several benefits to thesepatients. Many patients with skin laxity and lipodystrophy becomecandidates for liposuction who otherwise not qualify for the procedure.For patients without preexisting skin laxity but with more significantlipodystrophy, a larger contour reduction can be performed withoutiatrogenic skin laxity. The procedure can be deployed as a singlecombined procedure for smaller fractional resections or as a stagedprocedure.

Directed closure of the fractional field is performed without suturingand is achieved with the application of an adhesive stent membrane asdescribed in detail herein. The fractional field is closed with anadhesive membrane using a number of methods. An example method includesanchoring the membrane outside the perimeter of the fractional field.Tension is then applied to the opposite end of the adhesive membrane.The body of the adhesive membrane is then applied to the fractionalfield row by row to the remaining skin within the field. The directionof application follows the selected vector of directed closure. Thisdirection of application at times is at right angles to Langer's linesbut is not so limited, and any direction of application can be chosenthat provides maximal aesthetic contouring.

Another method includes use of the elastic property of the adherentstent dressing to selectively close a fractional field. With thismethod, the ends of the elastic stent dressing are stretched orpreloaded, and the stent dressing is then applied to the fractionalfield. Upon release of the ends of the membrane, the elastic recoil ofthe stent dressing closes the fractional defects in a direction that isat right angles to the elastic recoil.

Embodiments described in detail herein include a skin Pixel ArrayDermatome, also referred to herein as a “sPAD”. The sPAD is a gangedmultiple-scalpet array comprising a multiplicity of individual circularscalpels. The circular configuration enables rotational torque to beapplied to the skin to facilitate incising. A coupling or linkage of thescalpets to an electromechanical power source is provided by series ofgears between each scalpet and a drive shaft, as described herein. Inaddition, a vacuum is created within a housing and configured forstenting stabilization during incising. The same vacuum capability canalso be applied as a pneumatic assist to apply additional axial (Z-axis)force during the incising duty cycle. Another vacuum application is theevacuation of incised skin plugs in the fractional field.

The sPAD includes numerous configurations as described in detail herein.FIG. 97 is a sPAD including a skived single scalpet with depth control,under an embodiment. FIG. 98 is a sPAD including a standard singlescalpet, under an embodiment. FIG. 99 is a sPAD including a pencil-stylegear reducing handpiece, under an embodiment. FIG. 100 is a sPADincluding a 3×3 centerless array, under an embodiment.

An instrument comprising a surgical drill is provided for use with thesPAD. FIG. 101 is a sPAD including a cordless surgical drill for largearrays, under an embodiment. FIG. 102 is a sPAD comprising a drillmounted 5×5 centerless array, under an embodiment.

Embodiments include a Vacuum Assisted Pneumatic Resection (VAPR) ArraysPAD, also referred to herein as a “VAPR sPAD”. FIG. 103 is a sPADincluding a vacuum assisted pneumatic resection sPAD, under anembodiment. The VAPR sPAD uses vacuum pressure configured to drive thescalpets from the sPAD into the treatment site. The VAPR sPAD is coupledor connected to a drill via a Drill Array Coupling (DAC). FIG. 104 is aVAPR sPAD coupled to a drill via a DAC, under an embodiment. The DACfixes the housing of the VAPR sPAD to the drill, while the hexagonaltubing allows the VAPR sPAD drive shaft to slide up and down during thetreatment. An externally supplied vacuum (not shown) is coupled orconnected to the VAPR sPAD via the vacuum port.

FIG. 105 depicts the VAPR sPAD in a ready state (left), and an extendedtreatment state (right), under an embodiment. With the vacuum and drilloperating, a single treatment cycle comprises placing the VAPR sPADagainst the treatment site, creating a seal between the housing and thetreatment site. Once this seal is established, the vacuum pulls thepiston with the rotating gears into the treatment site. After thedesired depth of cutting has been achieved the SPAD is pulled away fromthe treatment site. This breaks the seal, and the spring inside the sPADforces it back into its ready state. The cycle can now be repeated at anew treatment site.

Embodiments include a Spring Assisted Vacuum Resection (SAVR) sPAD,which operates in a similar manner to the VAPR sPAD. FIG. 106 depictsthe SAVR sPAD in a ready state (left), and a retracted state (right),under an embodiment. The SAVR sPAD is coupled or connected to the drillvia the DAC. The vacuum port is attached to a separate vacuum supply.The drive shaft slides back and forth within the tube attached to thedrill.

In the SAVR sPAD, the spring and vacuum locations have generally beenreversed from the VAPR sPAD. The spring and vacuum port are both locatedon the proximal side of the piston but are not so limited. The vacuumassists in drawing the skin pixels out through the scalpets and henceaway from the treatment site. The spring provides the axial force forthe rotating scalpets to drive into the treatment site and resect theskin. The scalpets are extended outside the housing in array readystate.

The treatment cycle starts with the placement of the scalpets over thedesired treatment location. The vacuum is turned on and the drill isapplied downward, forcing the piston and scalpets back up into thehousing (retracted state). The drill is turned, causing the scalpets torotate. The spring force coupled with the scalpet rotation results inthe resection. The vacuum draws the pixels generated by the resection upinto and subsequently out of the housing. Once the desired cutting depthhas been achieved, the SAVR sPAD is lifted off the treatment site andthe cycle can be repeated.

Embodiments are described herein comprising instrumentation andprocedures for aesthetic surgical skin tightening including, but notlimited to, instruments or devices, and procedures that enable therepeated harvesting of skin grafts from the same donor site whileeliminating donor site deformity. Embodiments herein include devicesconfigured for fractional resection and corresponding methods orprocedures, including single-scalpet and multi-scalpet array platformsusing a vacuum manifold. Additional disclosure of corresponding devicesconfigured for fractional resection and corresponding methods orprocedures is found in the Related Applications, each of which is hereinincorporated by reference in its entirety. Regarding the use of vacuumin a fractionally resected field, the vacuum manifold is configured toapply vacuum intraluminally within the scalpet (or within amulti-scalpet array). Alternatively, the vacuum manifold is configuredto apply vacuum extraluminally as either a component of the scalpetassembly or as a separate manifold device that is directly applied tothe skin of the fractional field.

Applications of the vacuum capacity of the scalpet assembly include thesuction evacuation of fractionally incised skin plugs (e.g., FIGS. 108,112, and 113). Furthermore, applications of the vacuum capacity of thescalpet assembly include the vacuum stabilization of the skin surfaceduring fractional resection (e.g., FIGS. 109 and 114). Additionalapplications of the vacuum capacity of the scalpet assembly includefractional vacuum-assisted lipectomy of the subcutaneous and subdermalfat layer (e.g., FIG. 114).

FIG. 107A is a cross-sectional side view of a carrier 1071 including avacuum manifold 1072, under an embodiment. FIG. 107B is an isometriccross-sectional side view of the carrier 1071 including the vacuummanifold 1072, under an embodiment.

FIG. 107C is a side view of the carrier 1071 including the vacuummanifold 1072, under an embodiment. The vacuum manifold 1072 isconfigured to be coupled or attached to a distal region of the carrier1071 and scalpet assembly/scalpet array 1073. The vacuum manifold 1072of an embodiment comprises a “slip-on” or overlay encasement configuredto be removeably coupled to the distal end of the carrier 1071. Thisembodiment includes a scalpet array 1073 with a single scalpet, but isnot so limited.

The vacuum manifold 107-2 includes a vacuum port 1074 configured tocouple to a vacuum source (not shown). The vacuum manifold 1072 of anembodiment also includes an aspirator (not shown) but is not so limited.The vacuum manifold 1072 is configured, for example, to couple to anaperture (e.g., distal, proximal, side, etc.) and/or lumen of thescalpet(s) 1073 to intraluminally direct vacuum force to the targetsite. Alternatively, the vacuum manifold 1072 is configured to directthe vacuum force to the target site extraluminally (not shown).

Vacuum delivery of the device of an embodiment is controlled by anaperture component configured for manipulation by a device operator.FIG. 108 is a solid side view of the carrier 107-1 with the vacuummanifold 1072 configured for manual control via an aperture 1075, underan embodiment. Alternatively, the vacuum component is controlledelectronically. For example, the cycling on/off of the vacuum source isat least in part computer controlled (e.g., computer controlled dutycycle, etc.). The electronic controller can also be used to cycle achange in the rotary (RPM) component of the scalpet assembly. Scalpetlength may also be one or more of manually and computer controlled.

The vacuum manifold 1072 of an embodiment is extended distally onto thescalpet to serve as a depth guide 1076, such that a distal end of thevacuum manifold 1072 is configured to control a depth of penetration ofthe scalpet array 1073 into the tissue. Various depth guide-dependentvacuum manifolds address different clinical applications and variabledermal depths at different anatomical sites. In an embodiment, a plasticmanifold is created as a single procedure disposable that has a separatevacuum port incorporated into the manifold, but embodiments are not solimited.

In an alternative embodiment, the vacuum capability is an “in-line” or“in-series” configuration of the carrier or handpiece through which thevacuum is applied internally and can extend down the length of the lumenand scalpet proximally or is diverted through a separate side apertureof the scalpet. FIG. 109A is an isometric view of a handpiece configuredto include or incorporate vacuum, under an embodiment. FIG. 109B is anisometric cutaway view of the handpiece configured to include orincorporate vacuum, under an embodiment.

FIG. 110A is a cross-sectional side view of a vacuum manifold 1101configured to be coupled or connected to an in-line vacuum component1102, under an embodiment. FIG. 110B is an isometric cross-sectionalview of a vacuum manifold configured to be coupled or attached to anin-line vacuum component, under an embodiment. FIG. 110C is a solid sideview of a vacuum manifold configured to be coupled or attached to anin-line vacuum component, under an embodiment. This embodiment includesthe vacuum manifol

FIG. 111A is a cross-sectional side view of a scalpet array used with avacuum aspirator, under an alternative embodiment. The device of thisembodiment includes a scalpet assembly 1111 including a scalpet array1112 with multiple scalpets, but is not so limited. FIG. 111B is anisometric cross-sectional view of a scalpet array used with a vacuumaspirator, under an embodiment. FIG. 111C is a side view of a scalpetarray used with a vacuum aspirator, under an embodiment. The vacuumaspirator is coupled or connected to the scalpet assembly and isconfigured as one or more of a specifically adapted aspirator forfractional resection, and a device such as a conventional surgicalaspirator or an aspirator used specifically for suction assistedlipectomy (SAL). In an embodiment, the intraluminal vacuum scalpet orscalpet array has a rotary component to enhance both a skin incisionaland fat suction curettage capability, but is not so limited.

FIG. 112 is a cross-sectional side view of a single-scalpet deviceapplied to a target tissue site, under an embodiment. This exampleoperational embodiment shows tissue extracted with vacuum force from afractional resection site via the lumen and side aperture of thescalpet. FIG. 113 is an isometric cross-sectional view of asingle-scalpet device applied to a target tissue site, under anembodiment.

FIG. 114A is a cross-sectional side view of a multi-scalpet deviceapplied to a target tissue site, under an embodiment. FIG. 114B is anisometric cross-sectional view of a multi-scalpet device applied to atarget tissue site, under an embodiment. This example embodiment showsuse of vacuum aspiration to remove fractionally resected tissue from thetarget site.

The scalpet devices of various embodiments include one or more scalpets.The scalpet types of an embodiment include one or more of a slottedscalpet and a slotted blunt micro-tip cannula. The scaplets or scalpetdevices of an embodiment include one or more apertures or orificespositioned axially in the scalpet adjacent the scalpet interior lumen,but are not so limited. FIG. 115 is an example scalpet 1150 includingapertures or slots 1151, under an embodiment. FIG. 116 is an exampleblunt micro-tip scalpet or cannula 1160 including apertures or slots1161, under an embodiment.

The ability to fractionally suction subdermal/subcutaneous fat underembodiments herein has several applications depending upon the targetanatomical region. These applications include without limitation, theflattening of a convex three-dimensional contour and the inwardcontouring of an anatomical region to restore an aesthetic feature suchas the submentum and the cervical-mandibular angle, for example. Forthese applications, a side-slotted aperture scalpet and a blunt tipside-slotted aperture fractional cannula are described herein. The blunttip cannula is configured for use in anatomical regions where keyvascular or nerve structures are immediately subjacent to the fractionallipectomy field. Regardless of the type of scalpet/cannula, thecombining of the rotary function of the system with a vacuum capabilityprovides a means to more effectively suction curette thesubdermal/subcutaneous fat layer.

Embodiments include, without limitation, fractional marking systemsconfigured as guides to assure an adequate fractional resection density.The guides include, for example, a stencil and/or AdherentSemitransparent Perforated Plastic Membrane Guide (ASPPMP) configuredfor use as a guide for fractional resection. The stencil marking systemincludes a stencil (e.g., ink, etc.) comprising a grid pattern of eithercircles or dots that is temporarily applied preoperatively to a targetsite. The circles or dots include at least one of a positive and anegative stencil of the grid pattern, and the ink material isbiocompatible and configured to not smear or degrade during prepping ofthe patient or during the conduct of the procedure. FIG. 117 is anexample negative stencil marking system, under an embodiment. FIG. 118is an example positive stencil marking system, under an embodiment.

The ASPPMP marking system includes an adherent semitransparentperforated plastic membrane. FIG. 119A shows a side view of the ASPPMPin use as a depth guide with the single-scalpet device, under anembodiment. FIG. 119B shows a top isometric view of the ASPPMP in use asa depth guide with the single-scalpet device, under an embodiment. Theperforated plastic membrane is also configured to serve as a depth guidethat assures that the prescribed depth of fractional resection is notexceeded.

Clinical applications of the single-scalpet and multi-scalpet arrayplatform include aesthetic contouring, which is most effectivelyproduced by a combination of skin tightening and inward contouring of anembodiment, but is not so limited. The ability to fractionally resectskin and fat during a procedure has produced a significant capabilityover previous electromagnetic devices and aesthetic plastic surgeryprocedures because the fractional resection includes the direct removalof skin (in an area of skin laxity) without visible scarring. Theenhanced capability of an embodiment to fractionally resect skin iscombined with fractional subdermal/subcutaneous lipectomy to restoremore youthful aesthetic contours.

FIG. 120 shows fractional resection of skin and fractionalsubdermal/subcutaneous lipectomy, under an embodiment. An example offractional resection of skin and fractional subdermal/subcutaneouslipectomy, without limitation, is the treatment of the submentum (underthe chin). FIG. 121 shows a side view of the submentum as a target areafor fractional resection of skin and fractional subdermal/subcutaneouslipectomy, under an embodiment. FIG. 122 shows an inferior view (lookingupward) of the fractional resection field submentum as a target area forfractional resection of skin and fractional subdermal/subcutaneouslipectomy, under an embodiment. The presence of skin laxity andprominence of the submental fat pad are the main components of thisaesthetic deformity. Each patient will have a variable amount of eachsoft tissue component requiring a selective correction tailored orconfigured for each particular patient. More specifically, the convexcontour of the submentum is caused predominately by lipodystrophy of thesubmental fat pad and the loss of the cervical-mandibular angle ispredominately due to skin laxity.

Patients typically present with a variable amount of submentum skinlaxity and lipodystrophy, so embodiments use planning and marking of apatient for a specific procedure. The combined capability of theassembly of an embodiment correlates well with the need to modify thespecific soft tissue components of the aesthetic deformity. For patientswith more severe skin laxity, a larger horizontally aligned treatmentarea in the submentum and lateral neck is marked for fractional skinresection. FIG. 123 shows a horizontally aligned treatment area in thesubmentum and lateral neck for severe skin laxity, under an embodiment.

For patients will more severe lipodystrophy, a broader fractionallipectomy (through fractional resection skin defects) is marked withinthe treatment area. The depth of the fractional lipectomy may also beselectively altered to address the topographic features of this convexcontour deformity. FIG. 124 shows broader fractional lipectomy in thesubmentum for severe lipodystrophy, under an embodiment.

Clinical applications of the single-scalpet and multi-scalpet arrayplatform include directed closure specifications. To promote primaryhealing (healing per primum) that reduces scarring, an accurate closureof the incision is a key principle employed in plastic surgeryprocedures. However, the direction of the closure is also important foraesthetic contouring. The appropriate vector of skin tightening takesinto account the anatomical structure to be aesthetically enhanced. Formore complicated aesthetic contours such as the face and neck, multiplevectors of sign tightening are employed during a procedure.

FIG. 125 shows example face vector and neck vector directed closures,under an embodiment. In addition to the skin tightening vectors, variouslines of closure also limit tension upon closure. Lines of closureinclude those described by Karl Langer, and FIG. 126 shows Langer'slines of closure. Closure of skin incisions as indicated by Langer'slines promotes primary healing because it reduces the tension of theclosure. When there is conformity between the vector of skin tighteningand Langer's lines, the resultant aesthetic contouring and primaryhealing will work in concert with each other to provide the optimalclinical outcome.

Embodiments herein include stepwise procedure algorithms configured toprovide a more uniform reduction to practice that produces predictableclinical outcomes. Many of the procedural steps (and the sequences ofsteps) herein are unique developments for fractional resectionprocedures. Without limitation, a procedural algorithm is included forthe fractional resection of the submentum.

According to the treatment procedures of an embodiment, initially, apatient is marked preoperatively in a sitting position. For patientswith relatively more skin laxity, the area outlined for fractionalresection is broader and extends onto the lateral neck. For patientswith relatively little or no skin laxity, the outlined fractionalresection area is limited to the area in which lipodystrophy of thesubmentum fat pad is producing a convex contour deformity. For patientswith both skin laxity and lipodystrophy, both areas are individuallyoutlined as components of a single combined treatment outline. FIG. 127shows marked target areas for fractional resection of neck and submentallipectomy, under an embodiment.

To avoid a reduction in the fractional field density, a local anestheticfield block is administered to the demarcated area of thesubmentum/neck. A dot/circle stencil is then applied to assure adequacyof the fractional resectional density, as described in detail herein.FIG. 128 shows an example marking stencil, under an embodiment. Theseprocedure steps can be reversed where stenciling is performed prior toinjection of the local anesthetic. The distension of the stenciled skincan be compensated with a larger outlined treatment area. A fractionalskin resection is then performed within the boundary of the entiredemarcated treatment area.

Fractional lipectomy is limited to the topographically outlined area oflipodystrophy (e.g., FIG. 127) and is performed either during fractionalskin resection or as a subsequent procedural step. Transitioning orfreehand feathering beyond the demarcated outline is performed tode-delineate the boundary of the fractional resection. A directedclosure of the fractional defects is performed with an absorbentadherent elastic bandage that is stretched (preloaded) in the preferredvector of closure/skin tightening.

The bandage (e.g., Flexzan, etc.) can be preloaded by first applying oneend of the bandage at a lateral mooring point beyond the fractionalfield. Once secure, the load is then applied at the opposite end of thebandage. The load is maintained during application. An alternativeloading technique is to first apply opposing loads at each lateralextend of the elastic bandage i.e., the bandage is first stretched alongthe longitudinal axis of the material prior to application. With theload being maintained, the elastic bandage is then fully applied to thefractional field. Release of the load results in an elastic recoil thatcloses the defects of the fractional field along the designated vector.In the submentum where skin laxity of the anterior neck is present, abi-directional closure with two vectors is pursued, but embodiments arenot so limited.

FIG. 129 shows example directed closure vectors of the submentum andanterior neck, under an embodiment. The vector for the anterior neck(below the submentum) is more transverse and is used to accentuate thecervical-mandibular angle. For the submentum, the vector of closure (asindicated by Langer's lines) is vertical. A sterile dressing is thenapplied to conclude the procedure. A compression garment is also appliedto provide compression and vectored support during the post-operativephase.

Embodiments include fractional scar revision. The reduction of thevisible impact of a pre-existing scar deformity has been a major focusof plastic surgery since the inception of this surgical specialty.Depending upon the type of scar deformity, different surgical techniqueshave been employed. A commonly employed technique is elliptical excisionof the scar with a layered closure. Other techniques such as Z-plastyand W-plasty attempt to reduce the linearity of the scar. FIG. 130depicts Z-plasty and W-plasty scar revision. However, these conventionaltechniques lengthen the scar deformity. Fractional scar revision isconfigured to reduce the visible impact of the scar without lengtheningof the scar.

For linear scar deformities, embodiments include a fractionalde-delineation technique in which an interdigitating fractionalresection is performed along each margin of the scar. To maximizede-delineation, directed closure of the fractional field is performed atright angles to the linear scar. FIG. 131 shows an example of thefractional de-delineation technique of scar resection, under anembodiment.

Additional de-delineation is produced under an embodiment with freehandfractional resection beyond the margins of the scar. Embodiments includea fractional technique for broad hypotrophic scars that occur fromshaved biopsy excisions of skin lesions. To reduce the width of the scardeformity, a fractional scar excision is performed within the margin ofthe scar. Directed closure is performed as described in detail herein.FIG. 132 shows an example of the fractional scar resection for broadhypotrophic scars, under an embodiment. Another alternative embodimentcombines both fractional scar revision techniques where the combinedrevision is performed as a single procedure or as a planned sequence ofprocedures, but is not so limited.

Additional embodiments include application of fractional resection toshorten incisions required to excise lesions. This novel capability canalso be applied to shorten longer plastic surgery incisions that areused to resect redundant skin. The elliptical extension of an incision(to avoid a “dog-ear” skin redundancy) is no longer required if thelateral aspect of each incision is fractionally resected using devicesand methods described herein.

The fractional procedure can be performed concurrently or as a plannedsubsequent revision of the primary excisional procedure. Fractionalresection of embodiments can also be used for pre-existing dog-earredundancies post excision. An example is the shortening of theinframmary incision required for breast reduction and breastrepositioning. FIG. 133 shows an example comprising shortening of theinframmary incision as applied to breast reduction and/or breastrepositioning, under an embodiment. The incision becomes less visible asit no longer extends beyond the inframmary fold.

Embodiments described herein include fractional skin grafting. Thisincludes the closure of full thickness skin defects, which has also beena primary focus of plastic surgeons. Large defects that cannot be closedby direct closure require a more complicated approach. The twoconventional approaches developed by plastic surgery are flap closureand skin grafting. FIG. 134 shows an example flap closure. Local ordistant flap closures require an intrinsic or pedicle blood supply thatis harvested with the flap at the donor site. Flap closure of skindefects is also complicated by the formation of additional scarring atthe donor site.

Skin grafting (either split thickness or full thickness) is the otherapproach used to close large full thickness skin defects. Using the skingrafting approach, skin graft donor sites are required and areassociated with significant scarring and morbidity.

After the several decades in which these two plastic surgical approacheshave been employed, a novel third approach is now described in theembodiments herein. Fractional skin grafting can avoid the side effectsassociated with sheet skin grafting because fractional skin grafting hasthe unique capability to avoid the donor site deformity associated withsheet skin grafting. Fractional skin grafting also provides theadditional capability to harvest subsequent skin grafts from the samedonor site. FIG. 135 shows an example comprising fractional skin graftharvesting to be applied to a donor site, under an embodiment.

Fractional skin grafting is especially important with patients havinglarge surface area burns for which donor site availability is severelylimited. This unique capability of serial harvest at the same donor siteis also important in patients with skin defects of the lower extremitythat are caused by reduced circulation. Patients such as these withvenous stasis, ischemic and diabetic ulcers are especially at risk tosustain the loss of the extremity if skin coverage of the vascularcompromised ulcer is not promptly obtained. Many of these patients mustundergo a sequence of skin grafts before skin coverage is obtained. Themorbidity associated with this prolonged skin grafting process involvingmultiple donor sites can be especially vexing in patients who also haveother serious systemic conditions. With fractional skin graftingdescribed herein, the absence of a single visible donor site deformitycoupled with the capability of serial harvesting of skin grafts from thesame donor site provides a uniquely capable treatment option for thesepatients. In comparison to split thickness skin graft donor sites, thedirected closure of the fractional donor site provides more rapidhealing that dramatically reduces donor site morbidity and scarring.

As the fractional skin graft of an embodiment is full thickness, thedurability of the skin coverage is also enhanced over split thicknessskin grafts. For wound healing in these compromised recipient sites, theapplication of the fractional skin graft can be performed without theforming of the fractional skin segments (pixels) onto a more uniformsheet. In this clinical setting, “side neovascularization” occursbetween the individual fractional skin segments and the recipient bed.FIG. 136 shows an example comprising neovascularization of a fractionalskin graft at a recipient site, under an embodiment. The recipient sitefunctions as a biological docking station that organizes the fractionalskin segments into a side orientation with the recipient bed.

For other non-compromised and more visible skin defects, embodimentsinclude the option to first form the fractionally harvested skinsegments into a more uniform graft at a mechanical docking station. FIG.137 shows an example docking station comprising a docking tray andadjustable slides, under an embodiment. In this clinical setting,“bottom up neovascularization” occurs from the recipient bed into deepaspect of dermis (e.g., FIG. 136). With each clinical setting, acompressive stent dressing provides additional support andimmobilization that promotes neovascularization or “take” of the skingraft.

Embodiments include a system comprising a carrier. The system includes ascalpet assembly configured to couple to the carrier, and comprising ascalpet array. The scalpet array includes at least one scalpetconfigured for at least one of fractional resection and fractionallipectomy of tissue at a target site of a subject. The carrier isconfigured to control application of a rotational force to the at leastone scalpet during the fractional resection and fractional lipectomy.The system includes a vacuum component coupled to the scalpet assemblyand configured to evacuate the tissue from the target site using vacuumforce.

Embodiments include a system comprising: a carrier; a scalpet assemblyconfigured to couple to the carrier, and comprising a scalpet array,wherein the scalpet array includes at least one scalpet configured forat least one of fractional resection and fractional lipectomy of tissueat a target site of a subject, wherein the carrier is configured tocontrol application of a rotational force to the at least one scalpetduring the fractional resection and fractional lipectomy; and a vacuumcomponent coupled to the scalpet assembly and configured to evacuate thetissue from the target site using vacuum force.

The tissue includes skin plugs incised to form the fractional fieldduring the fractional resection, and fat removed through the fractionalfield during the fractional lipectomy.

The at least one scalpet includes a lumen extending at least partiallyfrom a distal end towards a proximal end of the at least one scalpet.

The vacuum component includes a vacuum manifold configured to couple toa distal end of the carrier, wherein the vacuum manifold includes avacuum port configured to couple to a vacuum source.

The vacuum manifold is configured to couple to the lumen and configuredto direct the vacuum force to the target site intraluminally via thelumen.

The vacuum manifold is configured to direct the vacuum force to thetarget site extraluminally.

A distal end of the vacuum manifold is configured as a depth guide tocontrol a depth of penetration of the scalpet array into the tissue.

A distal end of the vacuum manifold is configured for use with a depthguide.

The vacuum manifold comprises an overlay encasement.

The vacuum manifold is removeably coupled to the distal end of thecarrier.

The vacuum component is configured for manual control of delivery of thevacuum force to the target site.

The system includes a controller configured to automatically control atleast one of the rotational force to the at least one scalpet anddelivery of the vacuum force to the target site.

The vacuum component includes a vacuum aspirator.

The vacuum force is configured for vacuum stabilization of the targetsite during the fractional resection.

The vacuum component is configured for placement in series with thecarrier and the scalpet assembly.

The vacuum component includes a carrier lumen in an interior region ofthe carrier, wherein the carrier lumen is coupled to the lumen of the atleast one scalpet, wherein the carrier lumen is configured to route thevacuum force to the target site via the lumen of the at least onescalpet.

The at least one scalpet comprises a cylindrical scalpet, wherein adistal region proximate to the distal end is configured to incise andreceive tissue.

The distal region includes a cutting surface.

The cutting surface includes at least one of a sharpened edge, at leastone sharpened point, and a serrated edge.

The cutting surface includes a blunt edge.

The lumen and the proximal end is configured to pass tissue from thetarget site.

The at least one scalpet includes at least one aperture positionedaxially in the scalpet adjacent the lumen.

The at least one scalpet includes a plurality of apertures positionedaxially in the scalpet adjacent the lumen.

The at least one aperture is configured to pass tissue from the targetsite.

The at least one aperture includes at least one cutting surface.

The at least one aperture is configured to divert received tissue atleast one of radially outward from the lumen and radially inward towardthe lumen.

The system includes a fractional marking system configured to indicatefractional resection density of a fractional field.

The fractional marking system comprises a stencil including a gridpattern of markers.

The stencil includes an ink stencil.

The stencil includes at least one of a positive stencil and a negativestencil.

The markers include at least one of circular markers and dot markersconfigured to mark the target site.

The markers include at least one notch to mark at least one corner ofthe fractional field.

The fractional marking system comprises a membrane includingperforations.

The membrane is configured as a depth guide to control a depth ofpenetration of the scalpet array into the tissue.

The membrane comprises a material including at least one of plastic,polymer, and composite, wherein the membrane is semitransparent.

The membrane is configured to adhere to the target site.

The lumen of the scalpet is coupled to a reservoir configured to retainreceived tissue.

The reservoir comprises a canister.

The carrier is configured to be hand-held.

The system includes a motor coupled to the scalpet assembly andconfigured to drive the at least one scalpet.

The scalpet array includes a plurality of scalpets.

Each scalpet is configured to rotate around a central axis of thescaplet.

The scalpet assembly includes a drive assembly coupled to each scalpet,wherein the drive assembly is configured to impart a rotational force toa proximal region of each scalpet, wherein the rotational force rotateseach scalpet around the central axis.

The drive assembly comprises at least one of a gear-drive system and africtional drive system.

The system includes a depth guide to control a depth of penetration ofthe scalpet array into the tissue.

The system includes a housing including a distal region coupled to thevacuum component and configured to form a vacuum seal when in contactwith proximate tissue adjacent the target site.

The scalpet assembly includes a spring device configured to control aposition of the scalpet array relative to the target site.

The vacuum force is configured to control a position of the scalpetarray relative to the target site.

The scalpet assembly includes a spring device configured to control aposition of the scalpet array relative to the target site in concertwith the vacuum force.

Embodiments include a device comprising a scalpet assembly configured tocouple to a carrier. The scalpet assembly includes a scalpet arrayconfigured for at least one of fractional resection and fractionallipectomy of tissue at a target site of a subject. The carrier isconfigured to control application of rotational force to scalpets of thescalpet array during the fractional resection and fractional lipectomy.The device includes a manifold configured to removeably couple to thescalpet assembly. The manifold includes a depth control deviceconfigured to control a depth of penetration of scalpets of the scalpetarray into the tissue. The manifold is configured to control a vacuumforce applied to evacuate the tissue from the target site. The tissueincludes skin plugs incised to form the fractional field during thefractional resection, and fat removed through the fractional fieldduring the fractional lipectomy.

Embodiments include a device comprising: a scalpet assembly configuredto couple to a carrier, wherein the scalpet assembly includes a scalpetarray configured for at least one of fractional resection and fractionallipectomy of tissue at a target site of a subject, wherein the carrieris configured to control application of rotational force to scalpets ofthe scalpet array during the fractional resection and fractionallipectomy; and a manifold configured to removeably couple to the scalpetassembly, wherein the manifold includes a depth control deviceconfigured to control a depth of penetration of scalpets of the scalpetarray into the tissue, wherein the manifold is configured to control avacuum force applied to evacuate the tissue from the target site,wherein the tissue includes skin plugs incised to form the fractionalfield during the fractional resection, and fat removed through thefractional field during the fractional lipectomy.

Embodiments include a device comprising a carrier comprising a proximalregion and a distal region. The proximal region is configured to behand-held. The device includes a scalpet assembly configured to coupleto the distal region. The scalpet assembly includes a scalpet arrayconfigured for at least one of fractional resection and fractionallipectomy of tissue at a target site of a subject. The scalpet arrayincludes scalpets that each comprise a tube comprising a hollow regionand a sharpened distal end configured to penetrate tissue at a targetsite of a subject. The device includes a manifold configured to coupleto the distal region. The manifold is configured to control a vacuumforce applied to evacuate the tissue from the target site. The tissueincludes skin plugs incised to form the fractional field during thefractional resection, and fat removed through the fractional fieldduring the fractional lipectomy.

Embodiments include a device comprising: a carrier comprising a proximalregion and a distal region, wherein the proximal region is configured tobe hand-held; a scalpet assembly configured to couple to the distalregion, wherein the scalpet assembly includes a scalpet array configuredfor at least one of fractional resection and fractional lipectomy oftissue at a target site of a subject, wherein the scalpet array includesscalpets that each comprise a tube comprising a hollow region and asharpened distal end configured to penetrate tissue at a target site ofa subject; and a manifold configured to couple to the distal region,wherein the manifold is configured to control a vacuum force applied toevacuate the tissue from the target site, wherein the tissue includesskin plugs incised to form the fractional field during the fractionalresection, and fat removed through the fractional field during thefractional lipectomy.

Embodiments include a method comprising configuring a carrier for atleast one of fractional resection and fractional lipectomy of tissue ata target site of a subject by coupling the carrier to a scalpet assemblycomprising a scalpet array. The method comprises configuring the carrierto control application of a rotational force to the scalpet array, andcontrol application of a vacuum force by a vacuum component coupled tothe scalpet assembly. The rotational force is configured to incisetissue at the target site. The vacuum force is configured to evacuatethe tissue from the target site. The tissue includes at least one ofskin plugs incised to form a fractional field during the fractionalresection and fat removed through the fractional field during thefractional lipectomy.

Embodiments include a method comprising: configuring a carrier for atleast one of fractional resection and fractional lipectomy of tissue ata target site of a subject by coupling the carrier to a scalpet assemblycomprising a scalpet array; configuring the carrier to controlapplication of a rotational force to the scalpet array, and controlapplication of a vacuum force by a vacuum component coupled to thescalpet assembly, wherein the rotational force is configured to incisetissue at the target site, wherein the vacuum force is configured toevacuate the tissue from the target site, wherein the tissue includes atleast one of skin plugs incised to form a fractional field during thefractional resection and fat removed through the fractional field duringthe fractional lipectomy.

The method includes marking the target site of the subject.

The marking comprises marking a perimeter of the target site of thesubject.

The marking comprises use of a stencil including a grid pattern ofmarkers.

The markers include at least one of circular markers and dot markersconfigured to mark the target site.

The stencil includes at least one notch to mark at least one corner ofthe fractional field.

The marking comprises marking at least one of a first region and asecond region at the target site.

The first region presents skin laxity.

The second region presents lipodystrophy.

The second region presents lipodystrophy of the submentum fat pad.

The method includes marking a plurality of fractional resection siteswithin the at least one of the first region and the second region.

The marking of the plurality of fractional resection sites comprisesapplying a fractional marking system to the at least one of the firstregion and the second region.

The method includes performing the fractional resection in the at leastone of the first region and the second region.

The method includes performing the fractional lipectomy in the secondregion.

The method includes performing the fractional lipectomy in the secondregion subsequent to the fractional resection.

The method includes performing the fractional resection in the secondregion subsequent to the fractional lipectomy.

The method includes performing the fractional lipectomy during thefractional resection.

The method includes de-delineating a boundary of the first region byfeathering beyond the boundary.

The method includes closing the fractional field of the fractionalresection, wherein the closing comprises directed closure.

The directed closure comprises at least one of closure substantially ina first direction, a plurality of directions, a substantially horizontalclosure, and a substantially vertical closure.

The directed closure comprises use of Langer's lines.

The directed closure comprises use of resting skin tension lines.

The directed closure comprises use of closure vectors of surgical skinresection procedures.

The directed closure comprises at least one of a bandage and an adherentmembrane instead of suturing.

The method includes applying a dressing at the target site.

The vacuum component includes a vacuum manifold configured to couple toa distal end of the carrier.

The vacuum manifold includes a vacuum port configured to couple to avacuum source.

The vacuum manifold is coupled to a lumen of at least one scalpet of thescalpet array and configured to direct the vacuum force to the targetsite intraluminally via the lumen.

The vacuum manifold is configured to direct the vacuum force to thetarget site extraluminally.

The vacuum component includes a vacuum aspirator.

The vacuum force is configured for vacuum stabilization of the targetsite during the fractional resection.

The method includes a controller configured to automatically control atleast one of the rotational force to the at least one scalpet anddelivery of the vacuum force to the target site.

The scalpet array includes at least one scalpet comprising a cylindricalscalpet including a lumen extending at least partially from a distal endtowards a proximal end of the at least one scalpet, wherein a distalregion proximate to the distal end is configured to incise and receivetissue.

The distal region includes a cutting surface.

The cutting surface includes at least one of a sharpened edge, at leastone sharpened point, a serrated edge, and a blunt edge.

The lumen and the proximal end is configured to pass tissue from thetarget site.

The at least one scalpet includes at least one aperture positionedaxially adjacent the hollow region.

The at least one aperture is configured to divert received tissue atleast one of radially outward from the lumen of the scalpet and radiallyinward toward the lumen of the scalpet.

The scalpet array includes a plurality of scalpets.

Each scalpet is configured to rotate around a central axis of thescaplet.

The scalpet array includes at least one scalpet, wherein the scalpetassembly includes a drive assembly coupled to each of the at least onescalpets, wherein the drive assembly is configured to impart arotational force to a proximal region of each scalpet, wherein therotational force rotates each scalpet around the central axis.

The configuring the carrier includes configuring the carrier for usewith a depth guide, wherein the depth guide controls a depth ofpenetration of the scalpet array into the tissue.

Embodiments include a method comprising configuring a carrier for atleast one of fractional resection and fractional lipectomy of tissue ata target site of a subject by coupling the carrier to a scalpet assemblycomprising a scalpet array. The method comprises configuring the carrierto control application of a rotational force to the at least onescalpet, and control application of a vacuum force by a vacuum componentcoupled to the scalpet assembly. The vacuum force is configured toevacuate the tissue from the target site. The tissue includes at leastone of skin plugs incised to form a fractional field during thefractional resection and fat removed through the fractional field duringthe fractional lipectomy.

Embodiments include a method comprising: configuring a carrier for atleast one of fractional resection and fractional lipectomy of tissue ata target site of a subject by coupling the carrier to a scalpet assemblycomprising a scalpet array; configuring the carrier to controlapplication of a rotational force to the at least one scalpet, andcontrol application of a vacuum force by a vacuum component coupled tothe scalpet assembly, wherein the vacuum force is configured to evacuatethe tissue from the target site, wherein the tissue includes at leastone of skin plugs incised to form a fractional field during thefractional resection and fat removed through the fractional field duringthe fractional lipectomy.

Embodiments include a method comprising generating a protocol usingpatient data. The protocol includes at least one target site and atopographical map of fractional skin resections configured forapplication at the at least one target site. The method comprisespositioning at the target site a carrier including a scalpet assemblycomprising at least one scalpet and a depth control device. The at leastone scalpet includes a lumen and a distal end configured to penetratetissue at the at least one target site. The method comprises performingat least one of fractional resection and fractional lipectomy bycircumferentially incising skin pixels at the at least one target siteusing the scalpet assembly, and controlling a depth of penetration ofthe incising using the depth control device. The method comprisesremoving at least one of the skin pixels and fat tissue underlying atleast a portion of the at least one target site via an orifice in the atleast one scalpet.

Embodiments include a method comprising: generating a protocol usingpatient data, wherein the protocol includes at least one target site anda topographical map of fractional skin resections configured forapplication at the at least one target site; positioning at the targetsite a carrier including a scalpet assembly comprising at least onescalpet and a depth control device, wherein the at least one scalpetincludes a lumen and a distal end configured to penetrate tissue at theat least one target site; performing at least one of fractionalresection and fractional lipectomy by circumferentially incising skinpixels at the at least one target site using the scalpet assembly, andcontrolling a depth of penetration of the incising using the depthcontrol device; and removing at least one of the skin pixels and fattissue underlying at least a portion of the at least one target site viaan orifice in the at least one scalpet.

Embodiments include a method comprising configuring a carrier foraesthetic contouring comprising fractional resection and fractionallipectomy of tissue by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent. The method comprises marking a target site of a subject. Themethod comprises generating a fractional field at the target site byfractionally resecting tissue according to the marking. The fractionalresection includes circumferentially incising and removing at least oneskin plug by application of the scalpet assembly. The method comprisesremoving fat tissue through the fractional field using the scalpetassembly, wherein the fat tissue is underlying at least a portion of thetarget site.

Embodiments include a method comprising: configuring a carrier foraesthetic contouring comprising fractional resection and fractionallipectomy of tissue by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent; marking a target site of a subject; generating a fractionalfield at the target site by fractionally resecting tissue according tothe marking, wherein the fractional resection includes circumferentiallyincising and removing at least one skin plug by application of thescalpet assembly; and removing fat tissue through the fractional fieldusing the scalpet assembly, wherein the fat tissue is underlying atleast a portion of the target site.

The marking comprises marking via application of the scalpet array.

The marking comprises marking a perimeter of the target site of thesubject.

The marking comprises marking at least one of a first region and asecond region at the target site.

The first region presents skin laxity.

The second region presents lipodystrophy.

The second region presents lipodystrophy of the submentum fat pad.

An area of the first region is larger than an area of the second region.

An area of the second region is determined based on a severity of thelipodystrophy.

The first region includes at least a portion of a submental space of thesubject.

The first region includes at least a portion of a lateral neck area ofthe subject.

The marking comprises marking a plurality of fractional resection siteswithin the at least one of the first region and the second region.

The marking of the plurality of fractional resection sites comprisesapplying a fractional marking system to the at least one of the firstregion and the second region.

The method includes performing the fractional resection in the at leastone of the first region and the second region.

The method includes performing the fractional lipectomy in the secondregion.

A depth of the fractional lipectomy is variable.

A depth of the fractional lipectomy is selectively controlled based ontopographic features of a convex contour deformity of the second region.

The method includes performing the fractional lipectomy in the secondregion subsequent to the fractional resection.

The method includes performing the fractional resection in the secondregion subsequent to the fractional lipectomy.

The method includes performing the fractional lipectomy during thefractional resection.

The method includes de-delineating a boundary of the first region byfeathering beyond the boundary.

The method includes closing the fractional field of the fractionalresection, wherein the closing comprises directed closure.

The directed closure comprises at least one of closure substantially ina first direction, a horizontal direction, a vertical direction, and aplurality of directions.

The directed closure comprises closure substantially along a firstvector and a second vector, wherein the first vector corresponds to aregion of a face and the second vector corresponds to a region of a neckof the subject.

The directed closure comprises use of Langer's lines.

The directed closure comprises use of resting skin tension lines.

The directed closure comprises use of closure vectors of surgical skinresection procedures.

The directed closure comprises at least one of a bandage and an adherentmembrane instead of suturing.

The method includes applying a dressing at the target site.

The configuring the carrier includes coupling a vacuum component to thescalpet assembly, wherein the vacuum component is configured to removethe tissue and the fat tissue using vacuum force.

The vacuum component includes a vacuum manifold configured to couple toa distal end of the carrier, wherein the vacuum manifold includes avacuum port configured to couple to a vacuum source.

The vacuum manifold is coupled to a lumen of the at least one scalpetand configured to direct the vacuum force to the target siteintraluminally via the lumen.

The vacuum manifold is configured to direct the vacuum force to thetarget site extraluminally.

The vacuum component includes a vacuum aspirator.

The vacuum force is configured for vacuum stabilization of the targetsite during the fractional resection.

The method includes a controller configured to automatically control atleast one of the rotational force to the at least one scalpet anddelivery of the vacuum force to the target site.

The at least one scalpet comprises a cylindrical scalpet including alumen extending at least partially from a distal end towards a proximalend of the at least one scalpet, wherein a distal region proximate tothe distal end is configured to incise and receive tissue.

The distal region includes a cutting surface.

The cutting surface includes at least one of a sharpened edge, at leastone sharpened point, a serrated edge, and a blunt edge.

The lumen and the proximal end is configured to pass tissue from thetarget site.

The at least one scalpet includes at least one aperture positionedaxially adjacent the hollow region.

The at least one aperture is configured to divert received tissue atleast one of radially outward from an interior region of the scalpet andradially inward toward the interior region of the scalpet.

The scalpet array includes a plurality of scalpets.

Each scalpet is configured to rotate around a central axis of thescaplet.

The scalpet assembly includes a drive assembly coupled to each scalpet,wherein the drive assembly is configured to impart a rotational force toa proximal region of each scalpet, wherein the rotational force rotateseach scalpet around the central axis.

The configuring the carrier includes configuring the carrier for usewith a depth guide, wherein the depth guide controls a depth ofpenetration of the scalpet array into the tissue.

Embodiments include a method comprising configuring a carrier foraesthetic contouring comprising fractional resection and fractionallipectomy of tissue by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent. The method comprises generating a fractional field at atarget site by fractionally resecting tissue. The fractional resectionincludes circumferentially incising and removing at least one skin plugby application of the scalpet assembly. The method comprises removingfat tissue through at least a portion of the fractional field using thescalpet assembly. The fat tissue is underlying at least a portion of thetarget site.

Embodiments include a method comprising: configuring a carrier foraesthetic contouring comprising fractional resection and fractionallipectomy of tissue by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent; generating a fractional field at a target site byfractionally resecting tissue, wherein the fractional resection includescircumferentially incising and removing at least one skin plug byapplication of the scalpet assembly; and removing fat tissue through atleast a portion of the fractional field using the scalpet assembly,wherein the fat tissue is underlying at least a portion of the targetsite.

Embodiments include a method comprising configuring a carrier forfractional scar revision by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent. The method comprises identifying at least one area adjacent ascar deformity as a target site of a subject. The method comprisesgenerating a fractional field by fractionally resecting tissue proximateto the least one area adjacent the scar deformity. The fractionalresection includes circumferentially incising and removing at least oneskin plug by application of the scalpet assembly.

Embodiments include a method comprising: configuring a carrier forfractional scar revision by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent; identifying at least one area adjacent a scar deformity as atarget site of a subject; and generating a fractional field byfractionally resecting tissue proximate to the least one area adjacentthe scar deformity, wherein the fractional resection includescircumferentially incising and removing at least one skin plug byapplication of the scalpet assembly.

The scar deformity includes a linear scar deformity.

The fractionally resecting tissue comprises fractionally resectingtissue along each margin of the scar deformity.

The method includes forming an interdigitating incised region on eachmargin of the scar deformity.

The method includes de-delineating a boundary of the incised region byfractionally resecting tissue beyond the respective margin.

The fractionally resecting tissue comprises fractionally resectingtissue at one or more ends of the scar deformity.

The scar deformity includes a broad scar deformity, wherein thefractionally resecting tissue comprises fractionally excising tissuewithin a margin of the scar deformity.

The fractionally resecting tissue comprises fractionally resectingtissue along each margin of the scar deformity, and fractionallyexcising tissue within a margin of the scar deformity.

The method includes forming an interdigitating incised region on eachmargin of the scar deformity.

The method includes de-delineating a boundary of the incised region byfractionally resecting tissue beyond the respective margin.

The method includes marking the target site, wherein the markingcomprises marking a plurality of fractional resection sites in the atleast one area adjacent the scar deformity.

The marking of the plurality of fractional resection sites comprisesapplying a fractional marking system to the at least one area adjacentthe scar deformity.

The method includes closing the fractional field of the fractionalresection, wherein the closing comprises directed closure.

The directed closure comprises directed closure approximatelyorthogonally to a direction of the scar deformity.

The directed closure comprises use of Langer's lines.

The directed closure comprises use of resting skin tension lines.

The directed closure comprises at least one of a bandage and an adherentmembrane instead of suturing.

The method includes applying a dressing at the target site.

The configuring the carrier includes coupling a vacuum component to thescalpet assembly, wherein the vacuum component is configured to removethe tissue using vacuum force.

The vacuum component includes a vacuum manifold configured to couple toa distal end of the carrier, wherein the vacuum manifold includes avacuum port configured to couple to a vacuum source.

The vacuum manifold is coupled to a lumen of the at least one scalpetand configured to direct the vacuum force to the target siteintraluminally via the lumen.

The vacuum manifold is configured to direct the vacuum force to thetarget site extraluminally.

The vacuum component includes a vacuum aspirator.

The vacuum force is configured for vacuum stabilization of the targetsite during the fractional resection.

The method includes a controller configured to automatically control atleast one of a rotational force to the at least one scalpet and deliveryof the vacuum force to the target site.

The at least one scalpet comprises a cylindrical scalpet including alumen extending at least partially from a distal end towards a proximalend of the at least one scalpet, wherein a distal region proximate tothe distal end is configured to incise and receive tissue.

The distal region includes a cutting surface.

The cutting surface includes at least one of a sharpened edge, at leastone sharpened point, a serrated edge, and a blunt edge.

The lumen and the proximal end is configured to pass tissue from thetarget site.

The at least one scalpet includes at least one aperture positionedaxially adjacent the hollow region.

The at least one aperture is configured to divert received tissue atleast one of radially outward from an interior region of the scalpet andradially inward toward the interior region of the scalpet.

The scalpet array includes a plurality of scalpets.

Each scalpet is configured to rotate around a central axis of thescaplet.

The scalpet assembly includes a drive assembly coupled to each scalpet,wherein the drive assembly is configured to impart a rotational force toa proximal region of each scalpet, wherein the rotational force rotateseach scalpet around the central axis.

The configuring the carrier includes configuring the carrier for usewith a depth guide, wherein the depth guide controls a depth ofpenetration of the scalpet array into the tissue.

Embodiments include a method comprising configuring a carrier forfractional skin grafting comprising fractional resection of tissue bycoupling the carrier to a scalpet assembly comprising a scalpet arrayincluding at least one scalpet, and a vacuum component. The methodcomprises marking a target site of a subject. The target site includes adonor site. The method comprises generating a fractional field at thetarget site by fractionally resecting tissue according to the marking.The fractional resection includes circumferentially incising andremoving a plurality of skin plugs by at least one application of thescalpet assembly. A skin graft comprises the plurality of skin plugs.The method comprises transferring and placing the skin graft at arecipient site.

Embodiments include a method comprising: configuring a carrier forfractional skin grafting comprising fractional resection of tissue bycoupling the carrier to a scalpet assembly comprising a scalpet arrayincluding at least one scalpet, and a vacuum component; marking a targetsite of a subject, wherein the target site includes a donor site;generating a fractional field at the target site by fractionallyresecting tissue according to the marking, wherein the fractionalresection includes circumferentially incising and removing a pluralityof skin plugs by at least one application of the scalpet assembly,wherein a skin graft comprises the plurality of skin plugs; andtransferring and placing the skin graft at a recipient site.

The removing of the plurality of skin plugs includes directing theplurality of skin plugs into a collection canister.

The transferring of the skin graft comprises non-uniform transfer of theplurality of skin plugs.

The non-uniform transfer of the plurality of skin plugs includesfree-form transfer.

The transferring of the skin graft comprises uniform transfer of theplurality of skin plugs.

The uniform transfer comprises transfer with a docking tray including aplurality of receptacles, wherein the docking tray receives theplurality of skin plugs removed from the donor site.

The docking tray maintains an orientation of the plurality of skin plugsremoved from the donor site.

The docking tray comprises an elastomeric material.

The uniform transfer comprises transfer with an adherent substrate thatcaptures the plurality of skin plugs from the docking tray.

The adherent substrate maintains relative positioning of the pluralityof skin plugs during transfer to and application at the recipient site.

The adherent substrate applies the skin plugs to the recipient site.

The adherent substrate aligns the skin plugs at the recipient site.

The placing of the skin graft at the recipient site comprises spreadingthe plurality of skin plugs over the area of the recipient site.

The spreading includes placing the plurality of skin plugs in contactwith the recipient site in a side orientation.

The plurality of skin plugs evokes side-neovascularization at therecipient site.

The spreading includes placing the plurality of skin plugs in contactwith the recipient site in a horizontal orientation.

The plurality of skin plugs evoke a side to end neovascularization atthe recipient site.

The plurality of skin plugs evoke a wound healing response at therecipient site.

The plurality of voids caused by removal of the plurality of skin plugsevoke a wound healing response at the donor site.

The marking comprises marking a plurality of fractional resection sitesat the target site.

The marking of the plurality of fractional resection sites comprisesapplying a fractional marking system to the target site.

The applying of the fractional marking system to the target siteincludes application of the scalpet array at the target site.

Application of the scalpet array at the target site produces an adequatefractional density harvest at the target site.

The marking comprises marking a second plurality of fractional resectionsites at the target site.

The method includes generating a second fractional field at the secondplurality of fractional resection sites using a second fractionalresection of tissue according to the marking.

The second fractional resection includes circumferentially incising andremoving a second plurality of skin plugs by at least one application ofthe scalpet assembly, wherein a second skin graft comprises the secondplurality of skin plugs.

The method includes transferring and placing the second skin graft atthe recipient site.

The method includes identifying a second target site of the subject,wherein the second target site includes a second donor site.

The method includes generating a second fractional field at the secondtarget site using a second fractional resection of tissue according tothe second marking.

The second fractional resection includes circumferentially incising andremoving a second plurality of skin plugs by at least one application ofthe scalpet assembly, wherein a second skin graft comprises the secondplurality of skin plugs.

The method includes transferring and placing the second skin graft atthe recipient site.

The vacuum component is configured to remove the tissue using vacuumforce.

The vacuum component includes a vacuum manifold configured to couple toa distal end of the carrier, wherein the vacuum manifold includes avacuum port configured to couple to a vacuum source.

The vacuum manifold is coupled to a lumen of the at least one scalpetand configured to direct the vacuum force to the target siteintraluminally via the lumen.

The vacuum manifold is configured to direct the vacuum force to thetarget site extraluminally.

The vacuum component includes a vacuum aspirator.

The vacuum force is configured for vacuum stabilization of the targetsite during the fractional resection.

The method includes a controller configured to automatically control atleast one of a rotational force to the at least one scalpet and deliveryof the vacuum force to the target site.

The at least one scalpet comprises a cylindrical scalpet including alumen extending at least partially from a distal end towards a proximalend of the at least one scalpet, wherein a distal region proximate tothe distal end is configured to incise and receive tissue.

The distal region includes a cutting surface.

The cutting surface includes at least one of a sharpened edge, at leastone sharpened point, a serrated edge, and a blunt edge.

The lumen and the proximal end is configured to pass tissue from thetarget site.

The at least one scalpet includes at least one aperture positionedaxially adjacent the hollow region.

The at least one aperture is configured to divert received tissue atleast one of radially outward from an interior region of the scalpet andradially inward toward the interior region of the scalpet.

The scalpet array includes a plurality of scalpets.

Each scalpet is configured to rotate around a central axis of thescaplet.

The scalpet assembly includes a drive assembly coupled to each scalpet,wherein the drive assembly is configured to impart a rotational force toa proximal region of each scalpet, wherein the rotational force rotateseach scalpet around the central axis.

The configuring the carrier includes configuring the carrier for usewith a depth guide, wherein the depth guide controls a depth ofpenetration of the scalpet array into the tissue.

Unless the context clearly requires otherwise, throughout thedescription, the words “comprise,” “comprising,” and the like are to beconstrued in an inclusive sense as opposed to an exclusive or exhaustivesense; that is to say, in a sense of “including, but not limited to.”Words using the singular or plural number also include the plural orsingular number respectively. Additionally, the words “herein,”“hereunder,” “above,” “below,” and words of similar import, when used inthis application, refer to this application as a whole and not to anyparticular portions of this application. When the word “or” is used inreference to a list of two or more items, that word covers all of thefollowing interpretations of the word: any of the items in the list, allof the items in the list and any combination of the items in the list.

The above description of embodiments is not intended to be exhaustive orto limit the systems and methods to the precise forms disclosed. Whilespecific embodiments of, and examples for, the medical devices andmethods are described herein for illustrative purposes, variousequivalent modifications are possible within the scope of the systemsand methods, as those skilled in the relevant art will recognize. Theteachings of the medical devices and methods provided herein can beapplied to other systems and methods, not only for the systems andmethods described above.

The elements and acts of the various embodiments described above can becombined to provide further embodiments. These and other changes can bemade to the medical devices and methods in light of the above detaileddescription.

In general, in the following claims, the terms used should not beconstrued to limit the medical devices and methods and correspondingsystems and methods to the specific embodiments disclosed in thespecification and the claims, but should be construed to include allsystems that operate under the claims. Accordingly, the medical devicesand methods and corresponding systems and methods are not limited by thedisclosure, but instead the scope is to be determined entirely by theclaims.

While certain aspects of the medical devices and methods andcorresponding systems and methods are presented below in certain claimforms, the inventors contemplate the various aspects of the medicaldevices and methods and corresponding systems and methods in any numberof claim forms. Accordingly, the inventors reserve the right to addadditional claims after filing the application to pursue such additionalclaim forms for other aspects of the medical devices and methods andcorresponding systems and methods.

What is claimed is:
 1. A method comprising: configuring a carrier foraesthetic contouring comprising fractional resection and fractionallipectomy of tissue by coupling the carrier to a scalpet assemblycomprising a scalpet array including at least one scalpet, and a vacuumcomponent; configuring the scalpet assembly to generate a fractionalfield at the target site by fractionally resecting tissue, wherein thefractional resection includes circumferentially incising and removing atleast one skin plug by application of the scalpet assembly; andconfiguring the scalpet assembly to remove fat tissue through thefractional field using the scalpet assembly, wherein the fat tissue isunderlying at least a portion of the target site.
 2. The method of claim1, comprising configuring the target site for the fractional resectionby marking via application of the scalpet array.
 3. The method of claim1, comprising configuring the target site for the fractional resectionby marking a perimeter of the target site of the subject.
 4. The methodof claim 3, wherein the marking comprises marking at least one of afirst region and a second region at the target site.
 5. The method ofclaim 4, wherein the first region presents skin laxity.
 6. The method ofclaim 5, wherein the second region presents lipodystrophy.
 7. The methodof claim 6, wherein the second region presents lipodystrophy of thesubmentum fat pad.
 8. The method of claim 6, wherein an area of thefirst region is larger than an area of the second region.
 9. The methodof claim 6, wherein an area of the second region is determined based ona severity of the lipodystrophy.
 10. The method of claim 6, wherein thefirst region includes at least a portion of a submental space of thesubject.
 11. The method of claim 10, wherein the first region includesat least a portion of a lateral neck area of the subject.
 12. The methodof claim 6, wherein the marking comprises marking a plurality offractional resection sites within the at least one of the first regionand the second region.
 13. The method of claim 12, wherein the markingof the plurality of fractional resection sites comprises applying afractional marking system to the at least one of the first region andthe second region.
 14. The method of claim 12, comprising performing thefractional resection in the at least one of the first region and thesecond region.
 15. The method of claim 14, comprising performing thefractional lipectomy in the second region.
 16. The method of claim 15,wherein a depth of the fractional lipectomy is variable.
 17. The methodof claim 16, wherein a depth of the fractional lipectomy is selectivelycontrolled based on topographic features of a convex contour deformityof the second region.
 18. The method of claim 15, comprising performingthe fractional lipectomy in the second region subsequent to thefractional resection.
 19. The method of claim 15, comprising performingthe fractional resection in the second region subsequent to thefractional lipectomy.
 20. The method of claim 15, comprising performingthe fractional lipectomy during the fractional resection.
 21. The methodof claim 14, comprising de-delineating a boundary of the first region byfeathering beyond the boundary.
 22. The method of claim 1, comprisingclosing the fractional field of the fractional resection, wherein theclosing comprises directed closure.
 23. The method of claim 22, whereinthe directed closure comprises at least one of closure substantially ina first direction, a horizontal direction, a vertical direction, and aplurality of directions.
 24. The method of claim 22, wherein thedirected closure comprises closure substantially along a first vectorand a second vector, wherein the first vector corresponds to a region ofa face and the second vector corresponds to a region of a neck of thesubject.
 25. The method of claim 22, wherein the directed closurecomprises use of Langer's lines.
 26. The method of claim 22, wherein thedirected closure comprises use of resting skin tension lines.
 27. Themethod of claim 22, wherein the directed closure comprises use ofclosure vectors of surgical skin resection procedures.
 28. The method ofclaim 22, wherein the directed closure comprises at least one of abandage and an adherent membrane instead of suturing.
 29. The method ofclaim 22, comprising applying a dressing at the target site.
 30. Themethod of claim 1, wherein the configuring the carrier includes couplinga vacuum component to the scalpet assembly, wherein the vacuum componentis configured to remove the tissue and the fat tissue using vacuumforce.
 31. The method of claim 30, wherein the vacuum component includesa vacuum manifold configured to couple to a distal end of the carrier,wherein the vacuum manifold includes a vacuum port configured to coupleto a vacuum source.
 32. The method of claim 31, wherein the vacuummanifold is coupled to a lumen of the at least one scalpet andconfigured to direct the vacuum force to the target site intraluminallyvia the lumen.
 33. The method of claim 31, wherein the vacuum manifoldis configured to direct the vacuum force to the target siteextraluminally.
 34. The method of claim 31, wherein the vacuum componentincludes a vacuum aspirator.
 35. The method of claim 31, wherein thevacuum force is configured for vacuum stabilization of the target siteduring the fractional resection.
 36. The method of claim 31, comprisinga controller configured to automatically control at least one of therotational force to the at least one scalpet and delivery of the vacuumforce to the target site.
 37. The method of claim 1, wherein the atleast one scalpet comprises a cylindrical scalpet including a lumenextending at least partially from a distal end towards a proximal end ofthe at least one scalpet, wherein a distal region proximate to thedistal end is configured to incise and receive tissue.
 38. The method ofclaim 37, wherein the distal region includes a cutting surface.
 39. Themethod of claim 38, wherein the cutting surface includes at least one ofa sharpened edge, at least one sharpened point, a serrated edge, and ablunt edge.
 40. The method of claim 37, wherein the lumen and theproximal end is configured to pass tissue from the target site.
 41. Themethod of claim 37, wherein the at least one scalpet includes at leastone aperture positioned axially adjacent the hollow region.
 42. Themethod of claim 41, wherein the at least one aperture is configured todivert received tissue at least one of radially outward from an interiorregion of the scalpet and radially inward toward the interior region ofthe scalpet.
 43. The method of claim 1, wherein the scalpet arrayincludes a plurality of scalpets.
 44. The method of claim 43, whereineach scalpet is configured to rotate around a central axis of thescaplet.
 45. The method of claim 1, wherein the scalpet assemblyincludes a drive assembly coupled to each scalpet, wherein the driveassembly is configured to impart a rotational force to a proximal regionof each scalpet, wherein the rotational force rotates each scalpetaround the central axis.
 46. The method of claim 1, wherein theconfiguring the carrier includes configuring the carrier for use with adepth guide, wherein the depth guide controls a depth of penetration ofthe scalpet array into the tissue.
 47. A method comprising: configuringa carrier for aesthetic contouring comprising fractional resection andfractional lipectomy of tissue by coupling the carrier to a scalpetassembly comprising a scalpet array including at least one scalpet, anda vacuum component; generating a fractional field at a target site byfractionally resecting tissue, wherein the fractional resection includescircumferentially incising and removing at least one skin plug byapplication of the scalpet assembly; and removing fat tissue through atleast a portion of the fractional field using the scalpet assembly,wherein the fat tissue is underlying at least a portion of the targetsite.